What is regulatory affairs?

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 regulatory matters for companies. TOPRA was established about 30 years ago as a professional membership organisation to represent and support them.

The regulatory professional

The regulatory professional’s job is to keep track of the 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 their research and development colleagues are generating.

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.

Avoiding problems

It takes anything up to 15 years to develop and launch a new pharmaceutical product and many problems may arise in the process of scientific development and because of a changing regulatory environment.

Regulatory professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

Marketing and advertising

In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.

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.

Working internationally

Many companies operating in high-technology healthcare and related industries operate on a multinational basis and are significant exporters. Their regulatory affairs departments must be aware of the regulatory requirements in all the company’s export markets.

Despite recent international efforts towards harmonisation of requirements, the regulations laid down by different governments and their interpretation by the regulatory agencies rarely match. The registration data prepared for one country frequently fail to meet the requirements for another.

Therefore great care has to be taken in drawing up efficient and economical research and development programmes whose results may be used as widely as possible. Regulatory professionals, with their detailed knowledge of the regulations and guidelines, are frequently called in to advise on such matters.

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