Drug regulatory affairs - 1

drug regulatory affaris

1. Regulatory Affairs By:- Tanuja Bisht Associate Professor Dehradun, Uttarakhand

2. Contents Introduction Historical overview Regulatory authorities Role of Regulatory affair department Responsibility of Regulatory Affair Professionals Scope of Regulatory Affair Professionals in Industries

3. Introduction Definitions:- Regulation: it includes variety of texts ( e.g , guidelines, recommendations, procedures, policies etc) that have different legal bases and authority. Drug Regulation: It is the control of drug use by international agreement/ regulatory authorities. Pharmaceutical Regulations: defined as combination of legal administrative and technical measures that government takes to ensure the safety, efficacy and quality of medicines, as well as, the relevance and accuracy of product information. Regulatory Affairs: regulatory affairs typically refers to that group of scientists who formulate the strategy for interacting with regulatory authorities in various countries as well as tactics of securing responses to questions dealing with submissions and maintaining communication post registration.

4. Regulatory Body: It is a public organization or government agency that is a set up to exercise a regulatory function. This involves imposing requirements, conditions or restrictions, setting the standard for activities, and enforcing in these areas or obtaining compliance. Regulatory Authorities: it is an autonomous authority or agency established by a federal, state or provincial government.

5. Regulatory affairs (RA) professionals play a crucial role in pharmaceutical industry and they provides strategic, tactical and operational direction and support to work within regulations so as to accelerate product development and provide safe and effective healthcare products or drugs to people around the world. RA also known as Govt. Affairs, is a profession within regulated sectors such as pharmaceuticals, medical devices, energy and banks.

6. Objectives of RA: Provide strategic and technical advice to R&D, production and quality control dept. File products in different markets. Helps in getting approval from the regulatory bodies. Tracks changes in legislation in the regions where the company distributes its products. Interpret and apply regulations. Develop and implement regulatory strategies. Collect, collate and evaluate scientific data. Improve performance of existing functions or activities through regulatory affairs personnel Share training resources where possible and use systematic approach to training. Provide advice to internal colleague on legal and scientific requirements.

7. Need for RA: Drugs are meant for improving public health, therefore, their development, manufacture, importation, subsequent handling and uses require specialized knowledge and skills and should conform to prescribed standards to strictly maintain their quality. Poor regulation can lead to release of standards, counterfeit, harmful and ineffective drugs to national and international markets resulting in serious harm to health of consumers. Main need is to provide the basis for assurance of high quality of drug products, which can increase consumer’s interest for ensuring the efficacy, quality and safety.

8. Regulatory Affairs Unapproved Product Investigational exceptions Initials Amendments Annual reports Lot release Adverse events Approval application Approval product Changes Annual reports License update Review meeting communication Inspection Review meeting communication Regulatory Authority Quality assurance Management License Product development Suppliers Clinical manufacturing Licensors Customers Marketing Legal Spectrum Of Regulatory Affairs

9. H istorical overview of RA: In the era of 1950s, multiple tragedies resulted in substantial increase of legislations and their strict implementation to maintain drug product quality, safety and efficacy. Some incidences are given as follows: Diphtheria Act led to 1902 Biologics Control Act Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act. Elixir of Sulfonamide led to the 1938 Food Drug and Cosmetic Act. Thalidomide led to the 1962 Kefauver- Harris Amendment. Dalkon Shield led to the 1976 Medical Device Amendment. Bjork- Shiley Heart Valves led to 1990 Safe Medical Devices Act.

10. India Till 20 th century, most of the drugs were imported from other countries. After First World War, with the increase in the demand of the drugs, channels opened for the substandard drug products in the market. To cope this situation, several regulations were made time to time. In the Era of 1900-1960: Poisons Act 1919: to control cheap drugs and their flow in the market, possession of substance specified as poison and their sale. Also describe safe storage of poisons, labelling and packaging of the poisons, max quantity to be sold and the inspection & examination of the poison sold by the seller in entire year. Dangerous Drugs Act 1930: to regulate cultivation, manufacture, possession, import, export and sale of opium and its plants. Drugs and Cosmetics Act 1940: to regulate the import, production, distribution and sale of drugs.

11. Pharmacy Act 1948: this law was amended lastly in 1986 and regulates the pharmacy profession in India . Drugs and Magic remedies (Objectionable Advertisements) Rules 1955: to control the advertisement of drugs in India. Drug Price Control Order (DPCO)1955: to review and fix maximum sale price for formulations as well as bulk drugs. It was lastly amended in 1995. b. In the Era of 1960-1990: Indian pharmaceutical industries were in initial growth stage, due to dependency on import, lack of R&D activities and existence of MNC’s in market. Indian Patent Act 1970: to protect patent in India. Under this only the process and manufacturing method of pharmacological substance obtained the patent. The product patent was not allowed under this law. It replaced the Indian Patent and Design Act of 1911. Narcotics and Psychotropic Substances Act 1985: issued to regulate the operation of narcotic drugs and substances and revoked the D angerous Drug Act 1930.

12. c. After the Era of 1990: R apid expansion and globalization of Indian pharmaceutical industry was observed in this time period. Paris cooperation Treaty 1999: India joined Paris Cooperation Treaty (PCT) in 1999,so as to protect Industrial property and patent rights in each of contracting state and implemented product patent effective from 1 st Jan 2005. Patent Amendment Act 2005: The Patent (Amendment) Act 2005 defines invention and clears about existing knowledge or thing cannot be patented. Herbal preparations having medicinal values can be patented under new amended law. Drugs and Cosmetics (First Amendment) Rules, 2011: mandate the registration of clinical research organization (CRO) to conduct clinical trials. Schedule Y1 of D&C Act suggests the requirements and guidelines for registration of CRO.

13. Regulatory Authorities: Any autonomous authority or agency established by a federal, state or provincial government is known as regulatory authority. Are established to enforce regulations on development and marketing of drug product and also regarding occupational health and safety. Country Regulatory Authority USA United States Food And Drug Administration (USFDA) UK Medicine And Healthcare Product Regulatory Agency (MHRA) Australia Therapeutic Goods Administration (TGA) India Central Drug Standard Control Organization (CDSCO) Europe European Medicines Evaluation Agency (EMEA)

14. International organizations World health organization (WHO) World trade organization (WTO) International conference on Harmonization (ICH) World intellectual property organization (WIPO) These regulatory agencies and organizations play an important role in all aspects of pharmaceutical regulations relating to the registration, production, distribution, price control, marketing, research and development of pharmaceutical products and intellectual property protection . The main challenges are ensuring safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures regarding development of medicines, control and compliance with legal obligations.

15. ROLE OF REGULATORY AFFAIR DEPARTMENT

16. Role of RA Department: It is a unique combination of science and management. Success of regulatory strategy depends less on regulation than on the way in which they are interpreted, applied, communicated within companies and to external components. It is a first point of contact between government authorities and company and helps in knowing, implementing and getting approval of these regulations laid down by various authorities and performs many functions in pharmaceutical industries.

17. RA in Product Management: Product registration and provide advice to companies both strategically and technically. Role starts from product development to production, marketing and post-marketing strategies and their advice at all stages, both in terms of legal and technical requirements. For countries not having their own regulatory bodies and regulations, the guidelines of WHO on Health and WTO on trade regulations are followed. Also the RA officer makes sure that labelling and packaging is done according to the proper guidelines given by regulation authority. RA in Clinical Trials: Develop strategies to overcome delays and submit the results of clinical trials to regulatory agencies for quick authorization, reducing approval time for new molecules. Also facilitates collection, analysis and communication of the risks and benefits of healthcare products for regulatory agencies, healthcare and medical system and the public. Also responsible for ensuring that market driven demands, government obligations and evolving scientific conventions are understood clearly and addressed by multiple stakeholders.

18. RA in R&D: RA department work together with marketing and research & development to develop novel product by taking advantage of new technological and regulatory developments to accelerates time to market. The use of adaptive clinical trial strategies, obtaining rapid regulatory approval and eliminating process difficulties can fasten the development of new products and helps in reducing costly errors and delays. RA in QA & QC: RA department in collaboration with QC department submit dossier containing the collected certificate of analysis, stability studies, analytical method validation reports and protocol for registration of the product. Collects Master Formula Records, process validation protocol, process validation report from QA dept and reviews them before submitting the dossier to regulatory authorities so as to get marketing approval or register the product.

19. RA in Licensing: RA dept using its thorough knowledge and links with government or regulatory bodies make the path easy to get license. RA dept also take care of documentation part to get permission from from concerned authorities. RA in Gathering Information: RA dept gathers and maintains information collected from regulators, expertise in drug development, colleague. RA uses this collected information on timely basis in order to ensure the compliance of regulatory standards for production of safe and effective medicines and betterment of company.

20. Thank You