Waqas Ali Khan

Article No. 27 Date:- Page |1 ROLE OF REGULATORY A AFFAIRS IN PHARMACEUTICAL SE SECTORS The pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, these are realizing that the real battle of survival lie in executing the work by understanding the guidelines related to various activities carried ried out to give an assurance that the p process rocess is under regulation. Pharmaceutical Industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a compr comprehensive manner.. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. A Regulatory Affair (RA) also has a very specific meaning with within in 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 Professionals. rofessionals. 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.. Pharma regulatory affairs professionals play an essential role ro in ensuring all pharmaceutical products comply with regula regulations tions governing the industry. Those working in Pharma regulatory affairs jobs not only work in the initial application phase for a new or generic drug, but also in the licensing and marketing stages- making sure all operations and products meet required safety and efficacy standards. Professionals must combine knowledge of the business, legal and pharmaceutical industries to determine if regulations are being followed and in many cases form the link between Pharma companies and regulatory Authorities, such as the Food and Drugs Agency (FDA) and the European Union Union. Regulatory affairs jobs in the UK and further field are generally within the pharmaceutical, chemicals, biotechnology, medical de devices vices and Cosmetics industries. Organizations such as the FDA also provide roles for those interested in working in the field. As biotechnology plays an increasing role within drug development and the pharmaceutical industry, growing numbers of biotech regulatory regulatory affairs positions are opening up. Inspection of biotechnology facilities requires a high level of technical knowledge due to the ever advancing dvancing systems bei being used. Pharmaceutical Drug Regulatory Affairs The person is responsible for knowing the regulatory requirements for getting new products approved. They know what commitments the company has made to the regulatory agencies where the he product has been approved approved.. They also submit annual Regulatory egulatory Affairs & Quality Operations Professional (Pharmaceuticals) (Pharmaceuticals | RA Freelancer & Consultant Article No. 27 Date:- Page |2 ROLE OF REGULATORY A AFFAIRS IN PHARMACEUTICAL SECTORS SE reports and supplements to the agencies. Regulatory Affairs Affairs typically communicates with one of the Centers (e.g., Center for Drug Evaluation and Research) at the FDA headquarters, rather than the FDA local district offices. Gimps do not directly apply to Regulatory Affairs; however, they must understand and eva evaluate luate changes to drug manufacturing and testing activities to determine if and when the FDA must be notified. Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlli controlling ng the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The companies responsible for the discovery, testing, manufacture and marketing marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. The Regulatory Affairs department will take part in the development of the product marketing concepts and is usually required to approve packaging and advertising before it is used commercially. Their Regulatory Affairs (RA) departments must be aware of the regulatory requirements in all the company’s export markets.. As an added complication, despite rece recent nt international efforts towards harmonization of requirements, the regulations laid down by different governments. Therefore great care has to be taken in drawing up efficient and economical research and development programs whose results may be used as w widely as possible. Regulatory Affairs professionals, with their detailed knowledge of the regulations and guideline-aa frequently called in i to advice on such matters.. Major Regulatory Authorities of Different Country-. India-CDSCO CDSCO (Central Drugs Standard Control Organization) US - USFDA (United States Food and Drug Administration) Japan-Japanese Japanese ministry of health Labor and welfare (MHLW) UK-Medicine Medicine and health care products Regulatory Agency (MHRA Australia-Therapeutic Goods Administration (TGA) Canada-Health Health Canada South Africa-Medicine Medicine Control Council ( MCC) Brazil-ANVISA Europe-European European Medicine Evolution Agency (EMEA) Regulatory egulatory Affairs & Quality Operations Professional (Pharmaceuticals) (Pharmaceuticals | RA Freelancer & Consultant Article No. 27 Date:- Page |3 ROLE OF REGULATORY A AFFAIRS IN PHARMACEUTICAL SECTORS SE The Drug Regulatory Affairs Professional The pharmaceutical research and development process of bri bringing nging a new drug to the market takes many years; it is therefore essential that the process be managed effectively from beginning to end in order to meet the regulatory requirements and permit a favorable evaluation of efficacy and safety in the shortest p possible ossible time. 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 post-marketing activities because regulatory environment is evolving rapidly toward global harmonization (several ICH guidelines guidelines)) and mutual recognition between different health authorities across the world, it is a major challenge for the DRA professional to keep abreast of policy changes and determine how these changes affect the approval process. The common point, however, is that the DRA professional is the primary liaison between the sponsor and the authority.. In this capacity, the individual must possess excellent writing and communication skills and be an effective negotiator. This is to ensure that the requests or comments generated during the submissions review process are promptly and satisfactorily answ answered ered and to negotiate the most favorable labeling (Product Monograph) consistent with the sponsor's sponsor's business objectives. objectives In line with today's growing technological developments, knowledge of several computer applications is essential to effectively fu fulfill lfill the job requirements. DRA is a dynamic, rewarding field that embraces both scientific and legal aspects of drug development. DRA professionals are dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples. Responsibility of Regulatory Affairs Professional’s The Regulatory Affairs professional’s job is to keep track of the ever 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 developmen colleagues are generating. They are responsible for the presentation of registration documents to regulatory y agencies, and carry out all the subsequent negotiations necessary to 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 developmentt 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 may take anything up to 15 years to develop and launch a new pharmaceutical Regulatory egulatory Affairs & Quality Operations Professional (Pharmaceuticals) (Pharmaceuticals | RA Freelancer & Consultant Article No. 27 Date:- Page |4 ROLE OF REGULATORY A AFFAIRS IN PHARMACEUTICAL SECTORS SE product and many problems roblems may arise in the process of scientific development and because of a changing regulatory environment [23].Regulatory affairs (RA) professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation 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 labeling or in advertising. advertisi List of responsibilities of Regulatory Affairs Department Departme 1. 2. 3. 4. 5. 6. -. 12. 13. Keep in touch with international legislation, guidelines a 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 ever-changing legislation 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, colla collate, te, and evaluate the scientific data that their research and development developmen 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/ approval approva are granted without delay. Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley Sarbanes Oxley compliance. Manage review audit reports and compliance, regulatory regulatory and customer inspections. Regulatory Affairs professionals help the company avoid avoid problems caused by badly kept record inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions Regulatory egulatory Affairs & Quality Operations Professional (Pharmaceuticals) (Pharmaceuticals | RA Freelancer & Consultant Article No. 27 Date:- Page |5 ROLE OF REGULATORY A AFFAIRS IN PHARMACEUTICAL SECTORS SE are also placed upon the claims which can be made for the product on labeli labeling or in advertising. 14. Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and eeffectiveness of the product. Conclusion Regulatory Affairs Profession believe the new appr approach oach 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. Most companies, whether they are major multinational pharmaceutical pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory affairs professionals and Regulatory affairs department is constantly evolving the one which is least impacted during the acquisition and merge merger, r, and also during recession. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. In today’s competitive environment the reduc reduction tion of the time taken to reach the market is critical to a product’s and hence within the company’s for their success and growth. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company. Regulatory egulatory Affairs & Quality Operations Professional (Pharmaceuticals) (Pharmaceuticals | RA Freelancer & Consultant