S.O.P. for Regulatory Affairs Department Introduction: Regulatory Affairs in pharmaceuticals (RA in pharma), also known as Government Affairs( Pharmaceutical regulatory affairs in pharmaceutical industry), this field in pharmaceutical industry is dealing with all aspects of government affairs , submitting products, getting license and registration of pharmaceutical products for sale and everything. Regulatory affairs departments are there in most of the regulated industries, like pharmaceuticals industry, medical devices, energy, and banking. What is Regulatory Affairs In Pharmaceutical Industry: - Regulatory Affairs (RA) is one of profession in pharmaceutical industry with great potential and opportunities, most of the pharma , biomedical ,companies in world have Regulatory Affairs department in their company. Regulatory Affairs profession in short can be described as process in a pharma company to collect, Analyze and Communicate the Benefits and the Risks and of a given Pharmaceutical or health care product to public as well as regulatory agencies all over the world. History: Pharmaceuticals industries were the first to be significantly regulated in the modern era. In 1980 the European Community (European Union) started the regulation of health care products in the member countries. The concept of regulating medicines was well established in most member countries along similar lines to the US. Pharmaceuticals and Health care or Pharmaceutical Regulatory Affairs Profession is still an emerging profession but has two major international professional membership societies: The regulatory professional typically has a background relevant to the business in which they work, i.e., science, medicine. Scope and Responsibilities: Responsibilities of Regulatory Affairs (RA) involves collecting data , analyzing and preparing and presenting documents for registration to regulatory authorities and perform all subsequent dialogue to gain and maintain marketing authorization (MA) for the products Pharmaceutical or health care product. Hence the Regulatory Affairs professionals are required to continue a track of every change happening in the laws and legislations in the countries where a product is being marketed or a company is going to market its product. Regulatory Affairs (RA) professionals not only do registration of pharmaceutical products, but they give an opinion to Pharmaceutical companies technically as well as strategically. They are involved right from right from development of a pharmaceutical product to manufacturing, marketing as well as post marketing studies. Advice of regulatory Affairs on legal and technical requirements saves big money and time for a pharmaceutical company right from developing to the production and marketing the same. Regulatory Affairs Core Functions: World over pharmaceutical industry is one of greatly regulated industry and there is great demand for peoples manages regulatory affairs. Pharmaceutical Regulatory Affairs professionals have responsibility in following areas: 1.To Ensure that their companies comply with all of the regulations and laws pertaining to their business. 2.To Work with federal, central, state, and local regulatory bodies and personnel on specific issues associated with their business, working with such agencies as the Food and Drug Administration, European Medicines Agency (pharmaceuticals and medical devices) 3.To advise their company on the regulatory affairs and climate that would affect proposed activities. describing the "regulatory climate" around issues like the promotion of prescription drugs compliance. Areas of Regulatory Affairs: Pharmaceutical regulatory affairs is a field in pharmaceutical industry which has good scope as the personnel is trained all topics related to pharmaceutical manufacturing and its regulation in various countries. The concern person is responsible for providing all technical data to pharmaceutical regulatory agency where he want to register the pharmaceutical product for sale, hence he must have knowledge 1. About Pharmaceutical Administration and Management, 2. How to Handling laboratory and manufacturing deviations 3. Pre approval inspections, 4. About Impact of Total Quality performance 5. GMP Certification and enforcement actions, 6.Maintenance and Update of Product Master Files , 7.Internal Compliance of Documentation 8.Coordination and Assembling of CTD/eCTD, 9.Quality systems, 10.Quality Assurance, 11.Method Validations, 12.Process Validations, 13Master Validation Plan, 14.Protocols 15.Standard Operating Procedures (SOPs) 16.Auditing and Compliance Functions 17.Regulatory strategies 18.Regulatory agencies 19.legislation and documentation systems as required for USFDA, UKMCA/UKMHRA, MCC, WHO etc. , FDA/UKMHRA Queries and submission , 20.Application requirements and guidelines , 21.Electronic submissions , 22.Medical device regulations , 23.Stability as per ICH ,guidelines & MBRs; International harmonization , Practice of regulatory affairs, 24.USP, Pharmacological, Toxicological and Clinical Trial Information, Re-registration Documents Design, 25.Role of the International Business Operations of the Pharmaceutical MNCs in Attracting the FDI, 26.Clinical Pharmacy, 27.Drug Trials and Vaccine Trials Guidelines, 28.Drug Laws , 30.IND training , 31.How to Format, assemble and submit the NDA, Human Genetic Research, 32.Clinical Trials, 33.Indian Ethics Committee, 34.Good Clinical Practices (GCP), 35.Pharmaco-vigilance and ADR reporting , 36.Clinical Trial Regulation, 37.Intellectual Property Rights, 38.Basis of Patentability, 39.Patent Application Procedure, 40.Compulsory License, 41.Infringement of Patents, 42.Product Registration for Regulated and Non Regulated Markets etc.