To succeed with a Marketing Authorisation extension or Variation, it is essential that Regulatory and Medical Affairs Teams work hand in hand 28 Jul 2020

Collaboration is vital in the pharmaceutical industry to foster desperately needed innovation.  We have seen this community spirit and cooperation working at its best over these last difficult months. In response to the COVID-19 crisis,  life science and healthcare professionals have joined forces across disciplines, countries and organisations to drive forward new therapies, diagnostics and vaccines.

Within our own organisations, it’s equally important that we forge strong cross-functional collaborations to bring medicines to patients efficiently and effectively.  At PharmaMedic, we often work particularly closely with colleagues in marketing and brand management to ensure proper medical oversight and input for any commercial materials.  Another crucial working relationship for medical affairs professionals is, of course, with the Regulatory Affairs Team.

Regulatory affairs groups play an instrumental role in any pharmaceutical company, contributing to the development and commercialisation of safe, effective medicinal products.  Their work encompasses a wide range of areas. These include amongst many others: the monitoring of current legislation, advising on legal requirements, developing regulatory documentation, and the presentation of documentation to agencies such as the MHRA to initiate and vary the Marketing Authorisations of new products.

Filing variations to existing licences, including those for extensions to Marketing Authorisations to support new indications, is also a central activity supported by regulatory affairs. While regulatory affairs personnel spearhead these efforts, medical affairs professionals also play a vital role in developing the case for why a given product should be modified on efficacy or safety grounds. This usually encompasses the need to place the patient’s health and welfare centre stage.

The PharmaMedic team has had many years of combined experience working for pharmaceutical sponsors and regulatory agencies. One key lesson learned from our experience working from both sides of the fence, is the importance of presenting a consistent, and compelling case on the medical justification for an extension or variation of a licence to support a client’s requirements.

Data and documentation serve this strategic objective, though they are not ends in themselves.  Without gathering the right input from all parties for your registration or variation request, you could be putting a successful outcome at risk.  At PharmaMedic, we are adept at working with in-house regulatory affairs teams, as well as liaising with Regulators themselves to help steer the process.  With decades of consultancy experience, we know how to build strong and effective relationships across the board with internal and external stakeholders to ensure a smooth path to registration.  We can also parachute in our seasoned regulatory affairs strategists to help with any given project, where a client doesn’t have an in-house resource in place.  By working closely together, as medical and regulatory affairs experts, we can ensure the best possible case is presented for your Marketing Authorisation extension to give you confidence in a robust medical position.

To learn more about how PharmaMedic can help your medical and regulatory efforts, get in touch to arrange a discussion.