Drug Regulatory Affairs

Introduction

• Regulatory Affairs (RA) is a profession within the healthcare industry namely, Pharmaceutical, Medical Device, Biologics, & Functional Food.
• Regulatory Affairs is a profession that has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
• RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and the public all over the world.
• Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices etc.
• This department is responsible for understanding the regulatory requirements for getting new /Generic products approved.
• They know the commitments that the company has made to the regulatory agencies where the product going to be approved. They also submit annual reports and supplements to the agencies.
• Drug Regulatory Affairs is a function that regulates pharmaceutical science in order to facilitate trade/business in and outside the country of origin for public interest.

What are Regulatory Affairs?

• Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
• Regulatory Affairs in the pharma industry may be defined as "The interface between the pharmaceutical company and the regulatory agencies across the world,"

Historical Overview for Regulatory Affairs

• During 1950's, many tragedies happened due to the misjudgment of the personnel during manufacture and some intentional addition of adulteration of substances into the pharmaceutical product which has lead to the death of patients.
• After so many incidents, the regulatory bodies introduced new laws and guidelines that improve the quality, safety and efficacy of the products
• Due to the rapid increase in laws, regulations, and guidelines for reporting safety, efficacy and quality of new medicinal products, the necessity for expert regulatory professionals arises tremendously.
• None of the drug manufacturing/marketing units are able to launch drug in the market until and unless the respective health authority (national/international) give a green signal in writing.
• Without fulfilling the requirements of the law of land, it is practically impossible to have drug products in the market.
• Almost two decades before, drug regulatory affairs were least known/needed by the pharmaceutical industry.
• It was in very nascent stage where registration executives were working under the export department.
• However, the situation has changed drastically where fully fledged Global Regulatory Affairs department become mandatory to define drug development, approval, and marketing strategy.
• Hence, the scope of Drug regulatory affairs has become vast, and experts are needed in health authorities and the pharmaceutical industry at various levels and departments.
• At the same time, the regulation pertaining to pharmacovigilance requirements mandates companies to monitor new drug safety aspects throughout the life cycle of the product.
• In this scenario, the role of the regulatory expert is very critical and important for deciding the entry strategy into various national and international markets.

Role of Regulatory Affairs Department

1. Ensuring that their companies comply with all of the system policy and laws pertaining to their business.
2. Working with federal, state, and local regulatory agencies and working with agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices).
3. Advising their companies on the regulatory aspects and climate that would affect proposed actions. i .e. describing the "regulatory climate“ in the region of issues such as the endorsement of prescription drugs.

Role of Regulatory Affairs Professionals in Health Authorities

A. Evaluation of Marketing Authorization Application

• New Drugs Application, New Biologics Application, Medical Device and Cosmetics Application, Generic Application, Clinical Trial Application, Variation Application, Drug Master Files for API, Excipients and Packaging Materials, Site Master File for GMP inspection.

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B. Support to Pharmaceutical Manufacturers

• Supporting Manufacturer in defining drug development pathway during Pre-NDA meeting and providing comments / confirming development pathway.
• From time to time meet with the pharmaceutical manufacturers association to discuss ongoing challenges, technical issues, guidelines/ guidance documents discussion and future development.

C. Monitoring of Drug Safety and Efficacy

• Monitoring Drug Safety by collecting Pharmacovigilance data and reviewing drugs in markets time to time by reviewing labels and taking appropriate action accordingly.
• Monitoring Clinical Trials as well as approving study results for next phase of study.

D. Regulatory systems and processes

• Keeping records for Drug Product Submission and Approval database
• Preparing Standard Operating Procedure (SOP) for efficient management of drug regulatory affairs department
• Be part of Regulatory forums/ conferences/webinars/seminars to exchange regulatory knowledge.

Regulatory Affairs in Clinical Trials

• The RA personnel develops strategies to overcome delays and presents findings of clinical trials to the regulatory bodies so as to get quick clearance thus reducing the time for approval of new molecules.
• At its core, the RA professional facilitates the collection, analysis and communication about the risks and benefits of health products to the regulatory agencies, medical and health systems and the public.

Regulatory Affairs in R & D

• The regulatory affairs personnel work hand in hand with marketing and R&D to develop, innovative products that take advantage of new technological and regulatory developments to accelerate time to market.
• With new products expected to add significant revenues to the company’s bottom lines, small decreases in time to market equate to large material gains in revenue and profit.
• Employing adaptive clinical trial strategies, obtaining quick approval from regulatory authorities, and avoiding pitfalls in processes can accelerate the development of new products and help to reduce costly errors and time lags.

Regulatory Bodies

• Regulatory bodies such as the Food and Drugs Administration (FDA) in the USA are responsible for approving whether a drug can proceed to clinical trials and whether it should be allowed to come into the market or not.
• This body has to evaluate the scientific and clinical data to ensure that the drug can be produced with consistently high purity, better therapeutic results and it does not have unaccepted side effects.
• It must also approve the labeling of the drug and the directions for its use or we can say a regulatory body has taken interest in all aspects of a drug design and its formulation.

Regulatory Bodies in the World

1. USA: Food and Drug Administration (FDA)
2. UK: Medicines and Healthcare Products Regulatory Agency (MHRA)
3. Australia: Therapeutic Goods Administration (TGA)
4. India: Central Drug Standard Control Organization (CDSCO)
5. Canada: Health Canada
6. Europe: European Medicines Agency (EMEA)
7. Japan: Ministry of Health, Labour & Welfare (MHLW)

Challenges

• The major challenges of these regulatory bodies are
• To promote public health and protect the public from harmful and dubious drugs,
• To establish proper legalization covering all products with a medicinal claim and all relevant pharmaceutical activities, whether carried out by the public or the private sector.
• To increase worldwide regulatory growth to ensure the safety of people.

Conclusion

Regulatory agencies and organizations around the world need to ensure the safety, quality, and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, monitoring, and ensure compliance with statutory obligations. However, the need of the hour is

1. More centralized procedures in drug regulation
2. Harmonization of regulatory norms 
3. Strengthening the regulatory authorities

The RA Professional Responsibility

• The drug regulatory affairs (DRA) professional plays an important role in every phase of this process, from developing regulatory strategies following the discovery of a new chemical entity to planning post-marketing activities.
• The main responsibility of the DRA professional within a pharmaceutical company is to secure approval of drug submissions from the Health Therapeutic Products Program (TPP) and to ensure regulatory compliance of marketed and investigational drugs with the Food and Drug Act and Regulations and TPP Guidelines/Policies.
• In this position, the DRA professional must possess a proficient scientific background (B.Sc, M.Sc., Ph.D., M.D. B. Pharm, M.Pharm or Pharm.D.) and have acquired a thorough knowledge of Indian regulations as well as international regulations.
• They are responsible for the presentation of registration documents to regulatory agencies and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned. They give strategic and technical advice at the highest level in their companies.
• Right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.
• It also helps the company to avoid problems caused by badly kept records, inappropriate scientific thinking, or poor presentation of data.

Importance of Drug Regulatory Affairs

• India is growing very rapidly in the pharmaceutical sector; there is a need of regulatory affairs professionals to cater the current needs of industries for global competition.
• Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies.
• They are required to be well-versed in the laws, regulations, guidelines, and guidance of the regulatory agencies.
• There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries.