Roll of RA in drug development
Drug regulatory affairs
The regulatory affairs department is responsible for protecting public health, but it is a highly complicated task that can be achieved only through extensive and complex regulation. Safety, efficacy, risk-benefit analysis, and quality are the core principles that are integral to drug regulatory affairs. The RA department is the backbone of the pharmaceutical industry and the key interface between the company and regulatory authorities. After completing the formulation manufacturing process than regulatory department match with standard reference and guidelines that ensure the quality of the new drug product basic principle of regulatory affairs is preparing and submitting dossiers to the health authorities . Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs 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 Regulatory Affairs 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. Regulatory Affairs 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.Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs 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 Regulatory Affairs 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. Regulatory Affairs 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.
Types, format and contents of submissions that the RA department is involved in
IND investigational new drug application ( for conducting clinical trial)
NDA new drug application ( new drug launch in market required )
ANDA abbreviated new drug application ( for generic drug approval )
DMF drug master file ( contain complete drug information )
CTA clinical trial application ( For clinical trial)
ICH ( International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
Regulation and Regulatory Affairs:
India is home to about 10,500 manufacturing units and over 3,000 pharma companies, and exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines. Everything from drug development and regulation to commercialization is highly regulated in the country. Every drug must undergo rigorous scrutiny and clinical trials before getting the market approval to ensure its quality, safety, and efficacy. In India, these standards are set by regulatory authorities orthe Drug Control Authority (DCA). Regulation impacts all aspects of the pharmaceutical domain, from pharmaceutical companies and independent innovators to regulatory or administrative bodies and patients.
The regulatory department holds a crucial link between drug products, companies, and regulatory authorities in determining the chances of drug development and the product to enter the market. Regulation involves a broad and extensive evaluation of a particular drug to ensure the protection of public health, drug registration, marketing authorization, pharmacovigilance, import, export, and distribution of the product. Regulatory Affairs is a blend of science and management that helps achieve the commercial goal of the drug-development organizations. RA takes care of everything from the development plan tosupervising/reviewing of the submission guidelines in the drug development and authorization process.
The Responsibilities of the Regulatory Affairs Professionals
The department of Regulatory Affairs is established to protect public health, by monitoring and controlling the safety and efficacy of drugs within several domains including pharmaceuticals, veterinary medicines, agrochemicals, cosmetics, medical devices, pesticides, and complementary medicines. The primary role of Regulatory Affairs is to provide strategic and technical advice to the pharmaceutical companies, right from drug development to the successful marketing of the product.
The Regulatory Affairs have the responsibility to keep the companies informed of the current government legislation, guidelines, regulatory intelligence, and customer practices. It also ensures that the company’s drugs and products comply with the existing regulations and makes sure the entire product range is kept up to date with the changing legislative practices. They also inform about the legal and scientific restraints, limitations, and requirements regarding the product and help companies collect, collate, and evaluate scientific information generated by the R & D department.
An essential role of Regulatory Affairsprofessionals also includes formulating regulatory strategies for companies to submit appropriate regulatory documents for both international, domestic,and/or contract projects.For export and import, the RA advises them about the international legislation and guidelines. They help high-level company executives to coordinate, prepare, and review all documents and submissions given to regulatory authorities, ensuring that they are clear, consistent, and complete from the regulatory perspective.
In today’s competitive environment, a proper conduct of the regulatory affairs activities is vital for the company’s success and sustainability of its products. The regulatory affairs in the pharma industry is what provides physicians and other healthcare professionals with a comprehensive and accurate information about the quality, safety, and effectuality of the drug/product.
As the healthcare industry is growing tremendously, it is necessary for the healthcare professionals to be equipped with industry knowledge along with their academic/technical skills and abilities. In that sense, the Indore Institute of Pharmacy (IIP), one of the best PCI approved pharmacy colleges in Indore, Madhya Pradesh, offers quality education that caters to the very needs of the industry and prepares the students accordingly. Established in the year 2004, Indore Institute of Pharmacy ensures a high focus on quality healthcare and pharmaceutical education that enables the aspirants to become dynamic and competent professionals. Ever since inception, the Indore Institute has been creating a strong foundation in the Pharmacy domain, equipping students with comprehensive knowledge and understanding of the Profession of Pharmacy and preparing them for a successful career.