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FDA Warns Taiwan Drugmaker Over GMP Violations

FDA

The US Food and Drug Administration (FDA) last month warned Taipei, Taiwan-based drugmaker Vida International over good manufacturing practice (GMP) violations following an inspection of the company’s Taoyuan City facility last December.

As a result of the observations made during the inspection, FDA placed Vida on import alert in March.

In the warning letter, FDA cites Vida for failing to conduct necessary batch testing for one of its products before release.

“You released an over-the-counter (OTC) drug product [redacted] to the US supply chain without testing the identity, strength, purity, and other quality of the active ingredient. In addition, you did not adequately test for critical microbial attributes (e.g., absence of objectionable microorganisms, total count) before release,” FDA writes.

FDA also says the firm failed to test incoming raw materials, including active ingredients, to determine their identity and whether they conform to written specifications before use.

According to FDA, Vida also prepared an inaccurate batch record for a lot of one of its drugs that did “not represent the formula and ingredients that the product purports on its label.”

FDA says the batch record did not list all the active ingredients specified on the drug’s label and did not include “the actual amounts of each active and inactive ingredient used during manufacturing, a calculation of theoretical or actual yields, documentation of the equipment used, and [other] critical manufacturing parameters.”

Additionally, FDA says the company failed to establish an adequate quality control unit, noting that the firm lacked adequate written procedures for functions, such as the release of batches and overseeing its drug stability program.

While Vida provided a response to FDA in December, the agency says the response is inadequate and requests that the company provide a plan for testing samples of all batches of drugs distributed to the US and conduct a risk assessment for all products distributed to the US within expiry to estimate the impact of its testing lapses.

They also asks the company to clarify whether it intends to resume manufacturing drugs at the facility for the US market, and if so to provide additional information on test methods and specifications and batch release specifications. Furthermore, FDA says the company will need to put in place corrective and preventative action (CAPA) plans to address deficiencies related to its stability program and quality control unit.

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What is Regulatory Intelligence (RI)?

regulatory intelligence
REGULATORY INTELLIGENCE (RI)

If we will search for REGULATORY INTELLIGENCE anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation.

Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities:

  • Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material.
  • Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to latest trends and patterns in the regulatory industry. Latest changes in regulatory and guidelines need to be implemented.
  • Regulatory Strategy: The key purpose to perform the above stated undertakings is to come up with the most appropriate and practical regulatory strategy for a company. Different products have different regulatory guidelines in different countries. This is why experts propose a plan of action that outlines an approach as to how to go about regulatory actions for the target distribution markets. However this plan of action is never a task done. It continuously goes forward as the mandates in the regulatory space change.

PHARMA ACTD DOSSIERS
REGULATORY INTELLIGENCE (RI)

This function of REGULATORY INTELLIGENCE(RI) typically conducts the following activities:


• Regulatory strategy, development plan or therapeutic area analysis for a product.
• Guidance interpretation and application.
• Due diligence
• Citizen’s Petitions
• Participation or observation of Advisory Committee or other public meetings.
• Identifying regulatory trends and anticipating effect on company and products.
• Monitoring health authority organisational changes.
• White papers or position statements.

Why is Regulatory Intelligence Important?


Provides the regulatory professional with information to:


– Identify opportunities.
• Broader indications, precise pre‐clinical/clinical development programs.
• Expedite development/increase efficiency.
– Identify possible pitfalls.
• Compliance issues, change in requirements for specific indication.
– Predict review times for product and/or change to product.
– Answer specific development questions posed by team.

USERS OF RI
USERS OF REGULATORY INTELLIGENCE (RI)

Benefits of Regulatory Intelligence (RI)
• Increased compliance.
• Increase likelihood of marketing application approval.
• Shorten time from filing to approval.
• Increased efficiency.
• Optimise study design for regulatory endpoints.
• Optimise messaging about product benefit.
• Maximise target market potential.
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Regulatory Strategy

strategy

First of all a therapeutic product’s regulatory strategy is a key component of product development. It is important that the regulatory strategy be developed very early in the drug-development process. As soon as the target product profile (TPP) has been determined, the regulatory strategy can be worked out as a pathway to support the TPP. The regulatory strategy is a reverse-engineered document such that once one has developed a TPP (i.e., the objective is established), one can then work backward to determine what information is needed to achieve the goal.

Within a company, there are usually many players from a variety of departments who work on developing the regulatory strategy. furthermore this strategy involves all aspects of a drug, individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs, and reimbursement should all provide input into the regulatory strategy to ensure it is as comprehensive as possible.

The clinical trial program should support the regulatory strategy. In other words, if the outcome of a clinical trial is not providing information that is supportive or pivotal to a future marketing application, its value should be questioned — at least in the early stages of drug development or in situations where cost plays a major role.
The main activities involved in creating and achieving a regulatory strategy include:

• conducting intelligence-gathering activities
• obtaining and managing documentation
• obtaining necessary approvals to conduct pre-clinical and clinical studies
• preparing for and attending regulatory authority meetings
• planning, preparing and maintaining regulatory submissions and correspondence
• responding to Agency queries and deficiency letters

Importance of the label and label claims
As part of the target product profile, a draft label will have been prepared. This will list the main proposed claims of the manufacturer. The regulatory strategy can then be developed to support these claims. Thus the TPP dictates key aspects of the clinical trial program.

Key aspects of a good regulatory strategy

A good regulatory strategy involves understanding the key guidelines and emerging policies, as well as the relevant stakeholders that stand between drug development and drug approval.

A good regulatory strategy identifies the pathway and the potential hurdles, and creates a plan that will proactively address any issues that may arise. A good regulatory strategy includes potential regulatory solutions for possible roadblocks.
Novel approaches or drugs with new mechanisms of action can present opportunities. With ongoing developments in science and medicine, the landscape continues to evolve and it is important for regulatory affairs professionals to engage an educational approach with regulators. Those who best understand a new drug are usually those who have developed it.

Thus it can be critical to educate regulatory agencies on how a drug or its mechanism may be unique, and that the existing regulatory guidelines and policies may not necessarily directly apply. Novel endpoints may be needed if the indication is new. This can pose challenges for drug development, but also it presents an opportunity to potentially identify new benefits and new strategies for obtaining marketing authorization.

Based upon the needs of regulators, a good regulatory affairs professional needs to be able to carefully evaluate development options and potential issues and challenges. The regulatory affairs professional is the communications intermediary between regulators and the rest of the drug development and marketing team. These individuals should be key members of the drug development team in order to best address any potential issues with regulators.
Regulatory strategy document
The regulatory strategy document has three main purposes. It needs to be:

• The tracking tool to summarize key agreements reached with health authorities
• The planning tool that documents timelines and lists topics to address in future meetings with health authorities
• The risk register to record key issues that could impact timelines, costs or commercial value for the project

Key components of a regulatory practices could include:

• A summary of relevant guidelines and precedents
• a strategy to optimize product label claims
• lifecycle management
• a global submission strategy
• target submission and approval dates
• special populations and special safety evaluations
• implications of licensing agreements
• regulatory risks
• details on exclusivity
• accelerated development and approval options
• trademark information
• a plan for future interactions with regulatory authorities
• key product-label attributes
• external influencing
• table of advice from regulatory authorities and outstanding commitments

Hence, there is no set way to develop a regulatory strategy. As a result, the Method chosen needs to take into account the company’s goals, over both the short and long term. Most noteworthy there can be trade-offs between speed and cost of development.

Therefore the regulatory method must strike a balance between what the company can afford, therefore what is needed to take the product to market with the identified TPP, and how fast the company can achieve drug development. The regulatory document should be almost a living document that evolves as drug development progresses and more is learned about the product.

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Abbreviation used in pharma regulatory

abbreviation

Abbreviation

An abbreviation is a shortened form of a word or phrase. It consists of a group of letters taken from the word or phrase. For example, the word abbreviation can itself be represented by the abbreviation abbr., abbrv., or abbrev.

Abbreviation used in pharma regulatory

Abbreviation Full name
M Micron
MCA Medicines Control Agency, now MHRA
ach Air changes per hour
ACOL Acceptable Carry-Over Limit
ADI Acceptable Daily Intake
ADR European Agreement on the Transport of Dangerous Goods by Road
AHU Air Handling Unit
AIM Active Ingredient Manufacturer
ANDA Abbreviated New Drug Application ( USA)
AP Applicant’s Part (of EDMF)
API(s) Active Pharmaceutical Ingredient(s)
APIC Active Pharmaceutical Ingredients Committee of CEFIC (website: http://apic.cefic.org)
APM Asset Performance Management
APR Annual Product Review
AR Annual Report
ASMF Active Substances Master File (Europe)
BACPAC Bulk Actives Post Approval Changes
Bioavailability A measure of extent of drug absorption in the body
Bioequivalence A study to demonstrate the equivalence of 2 medicines
BLA Biologies Licence Application (FDA)
BP British Pharmacopoeia
BPC Bulk Pharmaceutical Chemical ( USA ) – includes Actives and non-Active
BPE Bulk Pharmaceutical Excipients
BMR Batch Manufacturing Record
B Batch
COA Certificate of Analysis
CBE Changes Being Effected (FDA)
CBER Centre for Biologies Evaluation and Research (FDA)
CCP Critical Control Point
CDER Centre for Drug Evaluation and Research
CEP See C of S
CEFIC European Federation of Chemical Industries – Conseil European des Federations de l’Industrie Chimique
CFRs US Code of Federal Regulations
CFU Colony Forming Unit
cGMP current Good Manufacturing Practices
CHMP Committee of Human Medicinal Products – part of EMEA
CIP Clean in Place
CMC Chemistry, Manufacturing and Control section of Registration Dossier
COMAH Control of Major Accident Hazard Regulations
COP Clean Out of Place
COSHH Control of Substances Hazardous to Health
CPMP Committee of Proprietary Medicinal Products now CHMP – part of EMEA
CPG Compliance Policy Guide (FDA)
CPP Critical Process Parameter
CQA Critical Quality Attributes
CT Clinical Trial
CTD Common Technical Document – Dossier for Products – ICH format
CVM Centre for Veterinary Medicines (FDA)
CVMP Committee for Veterinary Medicinal Products – part of EMEA
DI De-ionised (Purified) water
DMF Drug Master File
DOP Dispersed Oil Particulates
DQ Design Qualification
DR Deviation Report
DS Drug Substance
DSM Drug Substance Manufacturer
EAM Enterprise Asset Management
EC European Commission
ECM Enterprise Calibration Management
EDMF European Drug Master File
EDQM European Directive for the Quality of Medicines
EDR Enhanced Design Review
EFD Engineering Flow Diagram
EFPIA European Federation of Pharmaceutical Industries Association
EINECS European Inventory of Existing Commercial Chemical Substances
EIR Establishment Inspection Report (FDA)
ELD Engineering Line Diagram
ELINS European List of Notified (New) Chemical Substances
EMEA European Medicines Agency
ER&S Electronic Records and Signatures
ERA Environmental Protection Agency
ERP Enterprise Resource Planning
EU Endotoxin Unit or European Union
Eudralex Rules Governing Medicinal Products in the European Union (European Drug Regulation Lexicon)
EWG Expert Working Group
FMEA Failure Modes and Effects Analysis
FD and C Act US Federal Food Drug and Cosmetics Act
FD-483 Official FDA form for inspection observations
FDA Food and Drug Administration
FIA Freedom of Information Act ( USA)
FIFO First In First Out
FS Functional Specification, Federal Standard (USA) engineering standards typically
g Gram
GAMP Good Automation Manufacturing Practices
GC Gas Chromatography
GCLP Good Control Laboratories Practices
GCP Good Clinical Practice
GEP Good Engineering Practices
GHS (CPL) Globally Harmonised System of Classification and Labelling of Chemicals (UN)
GLP Good Laboratory Practice (applies to toxicology laboratories/studies)
GMP Good Manufacturing Practice
GxP Good “x” Practices = GMP, GAMP, GCLP, etc.
HACCP Hazard Analysis, Critical Control Point
HAZOP Hazard and Operating Studies
M Micron
HEPA High Efficiency Particulate Air filter
HPLC High Pressure Liquid Chromatography
HR Human Resources
HTM Health Technical Memorandum
HVAC Heating Ventilation and Air Conditioning
IATA International Air Transport Association
ICAO International Civil Aviation Organisation (UN)
ICH International Conference on Harmonisation ( USA , EU, Japan)
IMDG International Maritime Dangerous Goods Code
IMO International Maritime Organisation
IMP(s) Investigational Medicinal Product(s)
IND Investigational New Drug ( USA)
IPC In Process Control
IPPC Integrated Pollution Prevention and Control
IPEC International Pharmaceutical Excipients Council
IQ Installation Qualification
IQA Institute of Quality Assurance (UK) (www.iqa.org)
ISO International Standards Organisation
ISPE International Society of Pharmaceutical Engineers (ww.ispe.org)
IT Information Technology
JP Japanese Pharmacopoeia
Kg Kilogram
LAF Laminar air flow
LD50 Lethal Dose where 50% of the animal population die
LOD Limit of Detection
LOQ Limit of Quantification
MA Manufacturing Authorisation
MAA Marketing Authorisation Application (Europe)
MACOL Maximum Acceptable Carry Over Level
MDD Maximum Daily Dose
Mfg Manufacturing
MHRA Medicines and Healthcare products Regulatory Agency (UK)
Mkg Marketing
ML Manufacturer’s Licence – UK Licence for Medicines Manufacturing sites
MRA Mutual Recognition Agreement
MRO Maintenance Repair and Operations
MRP Manufacturing Resource Planning
MSDS Material Safety Data Sheets
N/A Not Applicable
NASA National Aeronautic and Space Agency ( U.S.A. )
NC Non-clinical (phase, studies)
NCE New Chemical Entity
NDA New Drug Application ( USA)
NF National Formulary ( USA)
NLT or > Not Less Than
NMT or < Not More Than
NOAEL No Observable Adverse Effect Level
NOEL No Observable Effect Level
NONS Notification of New Substances Regulations 1993 (EU)
OE Office of Enforcement, FDA
OEL Occupational Exposure Level
OHH Occupational Health and Hygiene
OOS Out of Specification
OQ Operational Qualification
ORA Office of Regulatory Affairs, FDA
ORO Office of Regional Operations, FDA
OSHA Occupational Safety and Health Administration ( USA )
OTC Over the counter medicine
P&ID Piping and Instrument Drawing
PAD Pharmacological Active Dose
PAI Pre Approval Inspection
PAR Proven Acceptable Range
PAS Prior Approval Supplement (FDA)
PAT Process Analytical Technology
PDA Parenteral Drug Association ( USA)
PDE Permitted Daily Exposure
PFD Process Flow Diagram/Drawing
Ph. Eur. European Pharmacopoeia
PHA (HazAn) Process Hazard Analysis
PhARMA Pharmaceutical Association of Research-based Manufacturers (PMA, USA )
Pharmacokinetics The study of the rate of adsorption of medicines in the body
P-I, P-II, P-III Phase I, Phase II, Phase III (in Clinical Trials)
PIC/S Pharmaceutical Inspection Convention/Cooperation Scheme
PL Product Licence – UK Marketing Authorisation (Dossier)
PLC Programme Logic Controller
PMA Pharmaceutical Manufacturers Association
POM Prescription Only Medicine
ppb Parts per Billion
PPE Personal Protective Equipment
ppm Parts per Million
PPM Planned Preventative Maintenance
PPQ Process Performance Qualification
PQ Performance Qualification or Process Qualification
PQG Pharmaceutical Quality Group (www.pqg.org)
PQR Product Quality Review
PS or P/S Particle Size
PTFE Polytetrafluroethylene
PV Process Validation
QA Quality Assurance
QC Quality Control
QOS Quality Overall Summary (of CTD)
QP Qualified Person
QSIT Quality Systems Inspection Technique
QU Quality Unit
QWP Quality Working Party
R&D Research and Development
RD Registration Dossier
RH Relative Humidity
RO Reverse Osmosis
RM Raw Material
RP Restricted Part (of EDMF)
RSM Registered Starting Material
SHE (or HSE) Safety, Health and Environment
SM Starting Material
SMF Site Master File
SOP Standards Operating Procedure
SPC Summary of Product Characteristics
SPC Statistical Process Control
SUPAC Scale-up, Post Approval Changes (FDA)
TAVC Total Aerobic Viable Count
TDI Tolerable Daily Intake
TGA Therapeutic Goods Agency ( Australia)
TLC Thin Layer Chromatography
TNTC Too Numerous To Count
TOC Total Organic Carbon
TSCA Toxic Substances Control Act 1976 ( USA )
TSE Transmissible Spongiform Encephalopathies (BSE)
TT Technology Transfer
TTR Technology Transfer Reports
TVC Total Viable Counts
U Units
ULPA Ultra Low Particulate Air Filter
URS User Requirement Specification
USP United States Pharmacopoeia
UV Ultra Violet
VMP Validation Master Plan
VOC Volatile Organic Compound
VSR Validation Summary Report
WFI Water for Injection
WHO World Health Organisation

 
these were the popular abbreviation used in pharma industry and these abbreviation are used when creating regulatory documents
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Regulatory Affairs Explained

Regulatory

Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. RA also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of RA professionals.

The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. RA plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. The drug development process is a lengthy, complex and extremely costly albeit necessary process.

Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug. Throughout the development stages, pharmaceutical companies have to abide by an array of strict rules and guidelines in order to ensure safety and efficacy of the drug in humans. In this highly regulated environment, regulatory affairs plays a critical role not only as the interface with health agencies and as a link between different departments in the company but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug.

Regulatory professionals keep working with the authorities and different departments within the company in order to meet regulatory commitments with the health authorities. Regulatory Affairs also ensures the maintenance of the marketing licence and leads life cycle extension activities such as broadening the indication of the drug, change of formulation, changes in the dosage etc..

Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.

Qualities of a good RA professional

  • Authoritative
  • Team Player
  • Decisive
  • resourceful
  • Good Communication Skill
  • Analytical Skill- Ability to evaluate the strengths and weakness of the technical and legal options open to a company.
  • Good Informational Technology skills
  • Negotiating Skills
  • Able to reapply scientific and regulatory principles
  • Ability to work with other disciplines
  • Flexible- Always willing to learn.

Responsibilities of Regulatory Affairs Department

  • Keep in touch with international legislation, guidelines and customer practices
  • Keep up to the date with a company’s product range
  • Ensure that a company’s products comply with the current regulations.
  • The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.
  • Formulate regulatory strategy for all appropriate regulatory submissions for domestic, international and/or contract projects.
  • Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization.
  • Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents.
  • Monitor the progress of all registration submission.
  • Maintain approved applications and the record of registration fees paid against submission of DMF’s and other documents.
  • Respond to queries as they arise, and ensure that registration/ approvalare granted without delay.
  • Impart training to R&D, Pilot plant, ADl and RA. Team members on current regulatory requirements.
  • Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the “regulatory climate” around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
  • Manage review audit reports and compliance, regulatory and customer inspections.
  • Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.
  • Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and effectiveness of the product.

Major Regulatory Authorities

  1. India-Central Drugs Standard Control Organization drug controller general of India (DCGI)
  2. US-Food and Drug Administration (US FDA)
  3. UK-Medicines and Health care products regulatory Agency (MHRA)
  4. Australia-Therapeutic Goods Administration (TGA)
  5. Japan-Japanese Ministry of health, Labour and Welfare (MHLW)
  6. Canada-Health Canada
  7. Brazil-Agency Nacional degradation Vigilancia Sanitaria (ANVISA)
  8. South Africa-Medicines Contol Council (MCC)
  9. Europe-European Directorate for Quality of Medicines (EDQM),European Medicines Evaluation agencies (EMEA)
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Our Services

Services
Our expertise in global drug development uniquely qualifies us as the provider of a variety of medical and regulatory services.It is important to have these local contacts so as to maximise the chance of a successful outcome in terms of a client’s regulatory strategy and/or licence submission.
Our professionals are all very experienced with many of them being leaders in their own field. As a direct result of the high calibre of our professionals, we are able to provide strategic advice (thinking ‘outside the box’) as well as ensuring compliance with all the current and relevant rules and regulations.

Medical and Clinical Consulting

Consulting on the Complete Product Development Program (all phases)
Reviewing and Assessing Clinical Protocols
Reviewing Safety and Efficacy Related Issues During Product Development
Adjudicating Clinical Data
Worldwide Drug Safety and Pharmacovigilance Services

Clinical Trial Safety Services
Post-Marketing Surveillance Services
Pharmacovigilance Consulting Services
EudraVigilance Reporting
Regulatory Support of New Chemical Entities

Global Regulatory Strategies
Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)
CMC (Chemistry, Manufacturing, Control)
Medical Writing
Labeling
Translations of Technical Documents
Coordination of Regulatory Certificates
In-licensing of Products for Marketing in the Emerging Markets

Assessment of Local Medical Need
Assessment of the Local Business Opportunity
Assessment of the Appropriateness of the Existing Documentation for an Approval in the Target Countries
Potential in-licensing of the Product
Serve as the Local Marketing Authorization Holder
Sales, Marketing, and Distribution Performed by a Local Distributor
Postmarketing Regulatory Maintenance
Regulatory Maintenance of Marketed Products

Life Cycle Management of Recently Marketed Products
Regulatory Maintenance of Older Products
CMC (Chemistry, Manufacturing, Control)
Post-Marketing Drug Safety & Pharmacovigilance
Labeling Updates and Harmonization of Labels
Product Transfers
Product Acquisitions (regulatory due diligence)
Company Mergers
Company Acquisitions (regulatory due diligence)
Regional Marketing Deals (co-promotion, co-marketing)
Coordination of Regulatory Certificates
Special Projects
Educational Activities

Training of personnel in pharmaceutical companies
Training of regulatory agency personnel from the emerging markets
Organizing meetings with drug development topics
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Regulatory Authorities for Drug Safety

Drug regulatory Authorities

Major components of the Food and Drug Administration (FDA) statutory authority have evolved in response to drug-related public health crises and in response to a changing environment.

The social and health care environment has changed and continues to evolve—health care providers and patients expect timely access to effective drugs, the user-fee program established in 1992 has increased the pace of drug review and approval, the practice of medicine and the use of medicines have changed, and the information available to the public from advertising and the Internet and from commercial and government or nonprofit sources has transformed consumer knowledge and the patient’s role in health.

In view of those changes, the agency’s regulatory authority must be reconsidered and strengthened to ensure that it is equal to the task. However, the committee cautions against assuming that altering the statute alone will solve all difficulties related to FDA’s regulatory authorities. FDA needs considerable new resources to perform optimally in a fast changing, challenging environment, including resources to support its regulatory activities, such as regulatory oversight of direct-to-consumer (DTC) advertising and staff with training and expertise in Medicine regulation.

HISTORY OF FDA DRUG REGULATION

The foundation of FDA’s regulatory authorities was laid in the 1906 Pure Food and Drug Act, which focused on misbranding and adulteration. In keeping with other consumer product laws, it focused on postmarketing remedies only. That is, if a medicine already on the market was proven to be a hazard, it could be seized and further sales halted.

In the wake of deaths due to elixir of sulfanilamide in 1937, the 1906 law was replaced with a stronger form of regulation in the Federal Food, medicine, and Cosmetic (FD&C) Act of 1938. The new law changed the emphasis to the period of time before a medicine enters the market, and required manufacturers to notify FDA before beginning testing on human subjects and to submit proof of the drug’s safety (though not of its efficacy) (Hutt, 1992).

The requirement was a major advance in drug regulation, but it was nonetheless still somewhat weak, as marketing could begin 60 days after submission of the information to the FDA unless the FDA affirmatively found the drug to be unsafe.

The statutory scheme for drug regulation went through yet another revision in 1962, after thousands of European children with limb defects were born to mothers who had been administered thalidomide (Kaplan, 1995; FDA, 2006). The Drug Amendments of 1962 shifted the burden of proof from FDA (which previously had to prove harm to keep a drug from being marketed) to manufacturers, who now were required to demonstrate both safety and efficacy prior to receipt of marketing approval (Hutt, 1991). The early 1960s also marked the crystallization of clinical trials into the sequence of phase 1, 2, 3 trials still in use today (DHEW, 1963).

The FDA’s ability to form judgments about the safety and efficacy of drugs depends upon the submission of data, usually from drug company sponsors, rather than on the use of data developed independently or on its own initiative. As a result, the statutory scheme governing drug approval in the United States has also included a series of measures to provide an incentive for third parties to develop safety and efficacy data for use by FDA.

These incentives include patent extensions (the Drug Price Competition and Patent Term Extension Act of 1984), and periods of market exclusivity in exchange for developing information about new medicines, new indications for old medicines, and new information about the action of old medicines in special populations, such as children (The Orphan Drug Act of 1982;

The FDA Modernization Act of 1997 [FDAMA]; the Best Pharmaceuticals for Children Act of 2002). Thus, the statutory scheme is characterized by carrots rather than sticks, in that the development of new information on drug safety and efficacy is achieved more by creating incentives than by issuing mandates.

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Pharma-IP Capabilities

 

ip capabilities

 

First of all Ip capabilities are a part of pharma industry. A pharma Document or regulatory document is useful if certain things are done accurately because We deal with pharmaceuticals that means many lives depends upon us and we have to recheck everything as we are related to world’s health. Even a single mistake can take million lives.hence we have to be very careful every time

 

Following are some of the Pharma IP Capabilities

➢ Review of literature.

➢ Evaluation of patents and planning of non-infringing route (if required).

➢ Strategy planning and execution of formulation development work.

➢ Searching of formulation patents.

➢ Analyzing and interpretation of claims.

➢ Suggesting non-infringing formulation for Formulation & Development

department.

➢ Drafting composition patent and prosecuting for different patent offices.

➢ Preparation of invalidation ground for different patents.

➢ Having patent searching, analyzing skill for ROW markets like Thailand,

Vietnam, Taiwan, North American Countries etc.

➢ Preliminary Patent Assessment Reports.

➢ Level clearance reports/ Freedom to operate reports for various markets.

➢ Drafting of Patent

➢ Prior Art Search / Patentability Search or Novelty Search using various

databases.

➢ Global Launch Calendar for constraining patents in issue.

➢ Searching patent equivalents in ROW countries, finding legal status and

giving IP comments.

➢ Giving possible entry dates for major markets & ROW countries.

➢ Patent Infringement Analysis for US, Europe, Australia, Canada & few ROW

countries.

➢ ANDA filing strategy for patents in Orange book.

➢ PPT’s for customer meetings based upon requirement & customer interest.

➢ Strategic opinion reports for the Invalidation or Non- infringement of

patents.

➢ Preliminary Reports for DCGI filing.

➢ Pre Grant opposition filings in India.

➢ Trade Mark Search.

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therefore you can check the website of government about all other acts and guidelines of the regulatory affairs of india Government site

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