Transition of Pharmaceutical Regulations: The New Regulatory Era after Brexit
Trivedi Ankit *
AGM, Regulatory Affairs, Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India.
Deshpande Shrikalp
K. B. I. P. E. R., Gandhinagar, Gujarat, India.
Zaveri Maitreyi
Department of Regulatory Affairs, Head of Department of Regulatory Affairs, K.B.I.P.E.R., Gandhinagar, Gujarat, India.
Jain Praveen Kumar
Regulatory Affairs, Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India.
Kolhe Kiran
AGM, Regulatory Affairs, Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India.
*Author to whom correspondence should be addressed.
Abstract
Aims: The current research paper describes the regulatory changes in different pharmaceutical sectors, which are affected after the Brexit and build new guidelines that were derived from the Medicines and Healthcare Products Regulatory Agency (MHRA).
Study Design: Retrospective and concurrent review were employed to get idea regarding the regulatory changes in various pharmaceutical sectors that took place after dissimilation of Europe and Britain.
Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., from January 2021 to April 2021.
Methodology: On January 1, 2021, the MHRA had published a library of new guidance that applied as the transition period came to an end. This guidance covers the various sectors of pharmaceuticals like Clinical trials, medical devices, Importing and Exporting of pharmaceuticals, Legislation, New licensing, Pharmacovigilance and Pediatrics, which are affected due to Brexit.
Results: The MHRA laid out the future BRITAIN requirements for registering clinical trials, legal representation and importing Investigational Medicinal Products (IMPs) after the end of the Brexit, Pediatric Investigation Plan (PIP) must be included in an application for BRITAIN marketing authorization (MA). Change in Licensing procedure and the Innovative licensing and access Pathway (ILAP) provides opportunities for enhanced regulatory and other stakeholder input, including interactions with National Institute for Health and Care Excellence. Early Access to Medicines Scheme (NICE.EAMS) providing access to unlicensed, promising treatments to patients who have life threatening or rare disease indications.
Conclusion: To ensure the new approach builds on our previous success and exploits the opportunities that arise from Brexit, the industrial strategy should adopt a sophisticated supply chain view to develop an empirical base for pragmatic, joined up policies to help pharmaceutical sector grow. These policies and support will drive the BRITAIN’s pharmaceutical sector in a Post-Brexit era.
Keywords: European Union, medicines and healthcare products Regulatory Agency, brexit, clinical trials, pediatric investigation plans, licensing of medicinal products, early patient access, orphan medicinal products, importing and exporting