A team of regulatory experts are critical to the efficient development of pharmaceutical products.
by Raymond E Peck, CEO of VxP Pharma
In order to legally sell a pharmaceutical product, it’s necessary to receive approval from regulatory organizations. These organizations exist at local, national and international levels, and are responsible for ensuring that medicines sold to people in their jurisdictions are of appropriate quality, safety and effectiveness. In addition, many regulatory bodies also monitor the storage, distribution, and even marketing and advertising of commercial drug products.
A single failure to meet regulatory guidelines can set a drug’s development back for months; or perhaps even remove it from that market altogether. Many regulatory agencies have the power to blacklist certain drugs, or to require that they be sold with warning labels, if those products fail to meet their standards. Even a failure to submit regulatory paperwork correctly can create significant delays in a drug’s release timeline.
For all these reasons, many pharmaceutical development firms choose to partner with contract manufacturing organizations (CMOs) that have experience in gaining regulatory approval for pharma products. Here’s a quick rundown of the functions performed by regulatory agencies, along with the structure and impact of a solid regulatory support strategy.
Regulatory agencies safeguard public health by filtering out unsafe pharmaceuticals.
Most national governments around the world have established agencies tasked with ensuring the legality, quality, effectiveness and safety of pharmaceutical products dispensed to their citizens. In the United States, the most powerful regulatory agency is the Food and Drug Administration (FDA), which works to make sure every drug sold in the US meets its regulatory obligations. On an international scale, the World Health Organization (WHO) works with national and local regulatory agencies to control the regulatory compliance of drugs sold in its member states.
In addition to performing quality and safety checks on the drugs themselves, regulatory authorities like the FDA and WHO also investigate the manufacturing processes, storage protocols, distribution routes and dispensation policies surrounding commercial drugs and clinical trials. These agencies also examine supply chains to ensure that no illegal or unfair trade practices are involved. They work to ensure that health care professionals and patients receive correct and complete information about each drug, and that advertising and marketing are fair and accurate.
Many CMOs provide regulatory support teams to help streamline regulatory approvals.
Even if a pharmaceutical firm’s practices are all in line with regulatory standards, the approval process itself can sometimes pose significant challenges. The most effective approach to gaining regulatory approval is to begin documenting all necessary data as early in the development sage as possible, to streamline the process of compiling a successful submission. This is exactly the expertise of a CMO’s regulatory support team.
The regulatory support team (sometimes known as “regulatory affairs,” or RA) collects information from the clinical department, as well as from sources in the manufacturing stage, the functional research team, and other nonclinical branches, throughout the entire development process. The team engages with experts working in all those areas, to ensure that all technical documentation remains accurate and up-to-date. Meanwhile, regulatory researchers assess guidelines provided by regulatory agencies like the FDA, the European Medicines Agency and the International Conference on Harmonization (ICH), in order to understand and ensure compliance with the latest rules and standards.
Regulatory support can significantly speed up the regulatory approval process.
As the drug moves closer to its clinical and commercial release dates, the team compiles all this data into research papers designed to meet the performance guidelines of the FDA, as well as other regulatory bodies. In fact, an experienced regulatory support team likely has personal contacts within several regulatory organizations, and can leverage these working relationships to maintain smooth communication and overcome any hurdles encountered along the way.
When a regulatory support team submits well written, well organized, easily accessible documentation, a pharmaceutical product can move much more rapidly from one stage to the next. Regulatory guidelines must be met at many stages of the development and manufacturing processes, and effective regulatory support is crucial in enabling the transfer of a product to a manufacturing facility, the licensure of the drug for clinical trials, and the final approval of a product for commercial sales.
In addition to being a writer and speaker, Raymond E Peck is the Founder and CEO of VxP Pharma Services and VxP Biologics, both based in Indianapolis Indiana.