Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling 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 of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.
A new class of professionals emerged to handle these regulatory matters for companies. TOPRA was established about 30 years ago as a professional membership organisation to represent and support them.
The regulatory professional
A regulatory professional is responsible for keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products, advise on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data.
They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned.
They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.