What is Drug Regulatory Affairs

Regulatory affairs is a comparatively new career stream which is evolved from...

What is Drug Regulatory Affairs Profession?

Regulatory affairs is a comparatively new career stream which is evolved from the need of governments to protect public health by regulating the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

The companies involved in the discovery, testing, manufacture and marketing of these products also want to make sure that their products are safe and make a valuable contribution to health and welfare of society. Regulatory affairs profession has emerged to handle these regulatory matters for companies.

Pharmaceutical Regulatory Affairs provide an overview of drug development and serves as a primary link between the company and the regulatory authorities. Pharmaceutical Regulatory Services professional should be responsible for keeping up with the increasing scope and complexity of the regulations. They are the main interpreters of the laws and regulation for other member of the company. They should have a good personality with good communication skills and should be well versed with current issues.

Responsibilities of Regulatory Affairs personnel in general can be summarized into three

  • Ensuring that their companies comply with all of the regulations and laws pertaining to their business,
  • Working with federal, state and local regulatory agencies and personnel on specific issues affecting their business
  • Advising companies on the regulatory aspects and climate that would affect their proposed activities.

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, advice on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data.

Regulatory Affairs Outsourcing Market

The worldwide market for pharmaceuticals is projected to grow from around $1 trillion in 2015 to $1.3 trillion by 2020, representing an annual growth rate of 4.9 percent. Several global demographic and economic trends are driving pharmaceutical consumption, including a rapidly aging world population and an associated rise in chronic diseases, increased urbanization and higher disposable incomes, greater government expenditure on healthcare and growing demand for more effective treatments.

Meanwhile, market growth is shifting toward emerging markets in Asia, Latin America and elsewhere, where pharmaceutical sales are forecast to expand at double digit rates. Further reforms of legislative systems, especially regarding patent protection and enforcement, as well as improving regulatory conditions, will make these markets increasingly attractive for U.S. industry.

In the past few years rate of outsourcing of regulatory affairs activities has increased across life sciences industries. Recent findings by Transparency Market Research state that the global regulatory affairs outsourcing market will exhibit a healthy 11.5% CAGR from 2015 to 2023. As a result, the market, which had a valuation of US$1.9 Bn in 2014 will rise to US$5.7 bn by 2023.

Clinical Trial Application and Product Registration Services to be Key Enabler of Growth Over the next few years, however, the market for regulatory affairs outsourcing witnesses the highest gains from the clinical trial applications and product registration segment. Factors such as patent expiries and the rising prevalence of a number of chronic, viral, and bacterial diseases have prompted biopharmaceutical companies in the development of a large number of new products. With the rising number of products in clinical trials, the demand for clinical trial application and product registration services is expected to substantially rise in the next few years.

Emerging Economies like India to be Key Enabler of Growth

Economic and competitive pressures in the healthcare industry continue to motivate life sciences companies to find ways of cutting costs. Companies aspiring to widen their global reach are increasing investments on R&D activities and new products are entering clinical trials and the market at a rapid pace. Undertaking regulatory affairs and the maintenance of huge data generated during the process can be a complex task for companies having a range of product portfolio and operations spread across diverse regional markets.

In the years to come, regulatory affairs service providers in emerging economies across regions like India are expected to bag the most numbers of outsourcing projects across the globe due to their cost advantage. An increased number of biopharmaceutical companies are using emerging economies as a launch pad for their venture in larger markets such as North America and Europe.

As a result, the market for regulatory affairs outsourcing market in emerging economies will offer the most lucrative and sustained growth opportunities for the global market. The market is expected to expand at a 15.8% CAGR in Asia Pacific and 11.1% CAGR across Latin America from 2015 to 2023.


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