Tag Archives: Regulatory Affairs Consultation

REGULATORY BODIES

A Regulatory Body (also regulatory authority, regulatory agency or regulator) is a public authority or government agency. It is responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity.

An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the  government. Regulatory authorities are commonly set up to enforce safety and standards.  Certainly to protect consumers in markets where there is a lack of effective competition or the potential for the undue exercise of market power.

Examples of regulatory agencies that enforce standards are :

Food and Drug Administration in the United States and the Medicines.

Healthcare Products Regulatory Agency in the United Kingdom.

SOURCE : WIKIPEDIA

Although regulatory affairs is real regulatory body for the  process but other departments are co-related too .
1 – Quality Control
2 – Quality Assurance
3 – Regulatory Affairs

Quality Control

Quality control (QC) is a process by which entities review the quality of all factors involved in production. Most noteworthy ” A part of quality management focused on fulfilling quality requirements.”

This approach places an emphasis on three aspects :

Elements such as controls, job management, defined and well managed processes, performance and integrity criteria. It also helps in  identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organisational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analysed).

Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.

the Quality Control operates a stringent system for release testing of raw materials, packaging materials, in process controls and final products through the use of the most modern analytical techniques and equipment supported by highly trained and experienced personnel. QC also undertake reference standard certification in compliance with cGMP regulations.

Quality Assurance

Quality assurance comprises administrative and procedural activities implemented in a quality system so that requirements and goals for a product, service or activity will be fulfilled. It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention.

This can be contrasted with quality control, which is focused on process output.
the Quality Assurance, independent of production, is responsible for the maintenance, compliance and further development of our internal quality management system. The Quality Assurance group guarantees that the pharmaceutical ingredients and other products comply with the respective requirements and are developed, produced, tested and released according to cGMP demands.

regulatory body

Regulatory Affairs

RA department assist clients with regulatory filing processes by providing full support in the compilation and maintenance of regulatory documentation. Hence it includes chemistry, manufacturing and control documentation, post-approval change documentation, type II Drug Master Files (DMFs), Certifications of Suitability to the Monographs of the European Pharmacopoeia (CEPs) and Active Substance Master Files for Europe (ASMFs).

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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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GMP(Good Manufacturing Practice)

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP

All guideline follows a few basic principles:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
  • Operators must be trained to carry out and document procedures.
  • Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
  • Any distribution of products must minimize any risk to their quality.
  • A system must be in place for recalling any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
  • GMP is also sometimes referred to as “cGMP”. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

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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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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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