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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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Regulatory affairs

Affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals, etc. Government affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Government affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:

• Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
• 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

Healthcare RA

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulation professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

• pharmaceuticals
• medical devices
• in vitro diagnostics
• biologics and biotechnology
• nutritional products
• cosmetics
• veterinary products

The regulatory professional’s roles are the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.

Core competencies

Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor’s degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.

Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.

Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.

Global aspects of regulatory affairs are taken up by organisations such as the Drug Information Association (DIA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Origins

The healthcare industries were the first to be significantly regulated in the modern era. Much of this regulation has stemmed from avoiding the repetition of disasters, and has tended to be led by the USA due to size of the market and its technological lead:

• Diphtheria Epidemic led to 1902 Biologics Control Act
• Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
• Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
• Thalidomide led to the 1962 Kefauver Harris Amendments
• Dalkon Shield led to the 1976 Medical Device Amendments
• Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act

In the USA, this regulation is largely written directly into law and codified in Title 21 of the Code of Federal Regulations

Recent developments

Starting in 1980 the European Union started to harmonize the regulation of healthcare products in the member states. The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device regulation.

Concurrently the EU had been developing the concept of New Approach Directives where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able).

The Europeans took the radical approach of applying the New Approach Directive to Medical Devices and by doing so made the first significant conceptual advance in healthcare regulation for nearly 100 years.
The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the international template.

Future developments

Many in the Medical Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety.

Medical Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the Medical requirements, some companies also choose to outsource or outtask Healthcare affairs to external service providers.

Medical Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

Regulatory affairs profession

The healthcare affairs profession is still an emergent profession but has four major international professional membership organizations:

• Drug Information Association, DIA
• The medical Affairs Professionals Society, RAPS
• The Organisation for Professionals in Regulatory Affairs, TOPRA
• Association of medical Affairs Professionals, ARAP
• Vietnam medical Affairs Society: VRAS

which offer education and training, professional development, competence certification and codes of ethics.
The Medical professional typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.

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Acts in Drug Registration

Acts

Basic Pharma Acts And Guidelines

Inception

first of all Acts and Guidelines are the main thing is inception.During any inspection of a pharmaceutical manufacturing facility all aspects of the WHO’s GMP guidelines for pharmaceutical products are checked in order to ensure that the facility follows those guidelines.

Some of the main points that should be checked for compliance are:• Quality Assurance
• Sanitation & hygiene
• Qualification & Validation
• Complaints & Recalls
• Personnel & Training
• Premises & Equipment
• Materials
• Documentation

Acts,Regulations & Guidelines

we understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements at home and in the regulated foreign markets.Hence We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section. Below are some of the acts and regulations

Indian Acts,Regulations & Guidelines:

International Acts, Guidelines And Regulatory Bodieswe are here to help Feel free to contact us at Email

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CDSCO Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India.
NPPA Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India.
D & C Act, 1940 The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
Schedule M Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.
Schedule T Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines.
Schedule Y The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act.
GCP guidelines The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR)has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice.
The Pharmacy Act,1948 The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
The Drugs and Magic Remedies (Objectionable
Advertisement) Act, 1954
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities.
The Narcotic Drugs and Psychotropic Substances
Act, 1985
The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.
WHO (Medicines) WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.
WHO sites WHO guidelines on all areas relevant to health of people all over.
ICH International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States
OECD Organization for Economic Collaboration and Developmentincluding 30 member countries covers economic and social issues in areas of health care.
EMEA European Medicines Agency (EMEA), a decentralised body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union.
US FDA Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.
TGA Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.
South Africa The department of Health, South Africa.
WTO News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations.
Codex Alimentarius Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.
MHRA News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK.
Health Canada Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.
Thai FDA Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.
HSA, Singapore Health Sciences Authority (HSA), the regulatory body of Singapore.
DOH, Philippines The Department of Health, Philippines.
Medsafe, New Zealand Medsafe, New Zealand Medicines and Medical Devices Safety Authority.
NPCB, Malaysia Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.
DGMP, Belgium Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.
BfArM, Germany Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany
SwissMedic Swiss regulatory agency for therapeutic products.
MPA, Sweden Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden.
NAFDAC, Nigeria News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.

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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.

AUTHOR : SAMPRGMR

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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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