Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects.
What Regulatory affair as a profession is?
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also have a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas:
1. Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
2. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
3. Advising their companies on the regulatory aspects and climate that would affect proposed activities. I.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
As a discipline, regulatory affairs cover a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. People who work in regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold.
The range of products covered is enormous, including foods and agricultural products, veterinary products, surgical equipment and medical devices, in vitro and in vivo diagnostic tools and tests, and drugs (which range from small molecules to proteins). The range of issues addressed is huge, such as manufacturing and analytical testing, preliminary safety and efficacy testing, clinical trials, and post marketing follow-up. Advertising issues, with a healthy dose of data management, document preparation, project management, budgeting, issue negotiation, and conflict resolution, are thrown in the mix.
Over the years, a complicated system of checks and balances has developed to set in place a process to efficiently and effectively regulate the marketing of products. On the industry side, people in regulatory affairs work with research scientists, clinicians, manufacturing groups, and sales and marketing groups to make sure that the government has the information it needs to judge a product. On the government side, people in regulatory affairs work to interpret and implement laws that Congress establishes to help protect the public. To carry out the congressional mandate, the Food and Drug Administration (FDA) requires pharmaceutical companies to generate and provide all the information deemed necessary to evaluate a given drug, biologic, and/or device with respect to safety and efficacy. This information is used by the agency to decide whether the product should be on the market—and if so, how it should be marketed and sold.
On the consumer side, people in regulatory affairs help keep the other two groups honest, and they provide the stimulus for Congress to enact the laws that regulate how government and industry treat products.
The Role of Regulatory affairs professional
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. It serves as the interface between the regulatory authority and the project team, and is the channel of communication with the regulatory authority as the project proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of RA to keep abreast of current legislation, guidelines and other regulatory intelligence. Such rules and guidelines often allow some flexibility, and the regulatory authorities expect companies to take responsibility for deciding how they should be interpreted. The RA department plays an important role in giving advice to the project team on how best to interpret the rules. During the development process sound working relations with authorities are essential, e.g. to discuss such issues as divergence from guidelines, the clinical study programme, and formulation development.
Most companies assess and prioritize new projects based on an intended Target Product Profile (TPP). The RA professional plays a key role in advising on what will be realistic prescribing information (‘label’) for the intended product. As a member of the project team RA also contributes to designing of the development programme. The RA department reviews all documentation from a regulatory perspective, ensuring that it is clear, consistent and complete, and that its conclusions are explicit. The department also drafts the core prescribing information that is the basis for global approval, and will later provide the platform for marketing. The documentation includes clinical trials applications, as well as regulatory submissions for new products and for changes to approved products. The latter is a major task and accounts for about half of the work of the RA department.
An important proactive task of the RA is to provide input when legislative changes are being discussed and proposed. In the ICH environment there is a greater possibility to exert influence at an early stage.
Why Regulatory Affairs as a Career??
The Pharmaceutical sector has been ever growing and with globalization the race to lead to be first is no more restricted by boundaries; companies need to dominate on a global level to stay on top. As a result of this competitiveness companies success lies in the “time taken” by the product to reach the market.
To achieve this Regulatory Affairs of a company must be conducted appropriately and systematically as this activity is of considerable economic importance for the company.
On an average it takes 15-20 years for a new drug development, and it cost around $800 million. With such an expensive and time consuming activity companies cannot afford a single day delay in getting the product to the market.
RA Professional play the very important role in getting the product to market, improper data reporting can delay evaluation of a positive marketing authorization. They play a crucial role right from the beginning of product development to post marketing authorization. An early correction in product development can save the company lot of time and money.
In appropriate labeling can call for an early recall of the product disturbing the company’s image and public confidence. Improper documentation can mean a product withdrawal, denial of MA.
A good RA professional will have a sound approach and plan his work systematically, he will co-ordinate effectively with the scientist and the regulatory agencies, he will foresight the possible risk and problems and communicate the same to the development team to prevent any future losses.
The best regulatory people work hand in-hand with marketing and R&D to develop innovative, risk-taking development plans that take advantage of new technological and regulatory developments to accelerate time to market
An RA professional is the first point of contact between the regulatory agencies and the companies.
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