Role Of Regulatory Affairs In Marketing Of Pharmaceutical Products
Keywords:Regulatory affairs (RA), Drug development, skills and abilities
The primary purpose of the rules governing medicinal products is to safeguard public health. However, this objective must be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. The Marketing Authorisation Holder (MAH) of a medicinal product is responsible for the quality, efficacy and safety of its products. The marketing authorization procedure includes an assessment of a dossier, in which the future marketing authorization holder (MAH) evidences the safety, efficacy, and quality of the product. Furthermore, the indications, contraindications, dosage of the product, general classification for supply, as well as the package leaflet for the patient and proposed texts on the labelling of the medicinal products are assessed. The Summary of Product Characteristics (SPC) forms part of the marketing Authorization. It serves as the key source of information about the medicinal product for doctors and healthcare professionals. Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. As the Pharmaceutical industry is expanding by leaps and bound no single country is capable of manufacturing all the drugs in required quantities at competing prices. Hence the Marketing Authorizations has become an essential part of Global Healthcare. Till sometime back Marketing Authorization procedures were country specific. The present study describes a brief review of Marketing Authorizations in various countries and regions around the world (WHO).