A Review on a Drug Registration Process in United Kingdom
Abstract
This review outlines the regulatory modifications in several pharmaceutical industries that have been impacted by Brexit and develops new standards-based recommendations from the Medicines and Healthcare Products Regulatory Agency (MHRA). To get insight into the regulatory changes that occurred in the pharmaceutical industry during the dissolution of Europe and Britain, retrospective and contemporaneous reviews were used. As the transition period concluded, the MHRA issued a library of new guidelines on January 1, 2021. The several pharmaceutical industries covered by this guidance include clinical trials, medical equipment, imports and exports of Pharmaceuticals and Cosmetics. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for approving medicinal products in the UK. The agency offers various routes for marketing authorisation, including national, international, and decentralised procedures. The national routes include a 150-day assessment, rolling review, European Commission (EC) Decision Reliance Procedure, decentralised and mutual recognition reliance procedure, and unfettered access procedure for marketing authorisations approved in Northern Ireland. International routes include Project Orbis and Access Consortium. Applicants must submit their applications through the MHRA submissions portal in electronic Common Technical Document (eCTD) format. The agency verifies the technical validity of submissions using the Lorenz Docubridge validation tool. The MHRA offers fast-track marketing authorisation for products with strong public health benefits or those addressing supply shortages. Applications that do not meet guidelines will be rejected, and applicants must resubmit after correcting errors. Understanding MHRA guidelines and requirements facilitates market entry for medicinal products in the UK.
Conclusion: Any medicinal agent to be marked in the United Kingdom has to follow the guidelines and regulations given by the MHRA a regulatory authority which approve drug products.
The objective of the review article is to highlights information regarding the requirements. Different types routes in registration of medicinal products in a market in the United Kingdom knowing the requirements of the MHRA guidelines, it is too easy for a product to get into the UK market.
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References
https://www.gov.uk/government/collections/licencing-how-to-apply
2. Medicines and Healthcare products Regulatory Agency “types of application legal basis” [Internet]. gov.uk; 2021 May 04 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/types-of-application-legal-basis
3. Medicines and Healthcare products Regulatory Agency” Apply for a licence to market a medicine in the UK” [Internet]. gov.uk;2024 Dec 18 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk
4. Medicines and Healthcare products Regulatory Agency. “150-day assessment for national applications for medicines” [Internet]. gov.uk;2024 Apr 16 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
5. Admin, Admin. UK and Great Britain Map - Ashlan Ninnetta - Explore ideas, tips guide and info. [Internet]. Ashlan Ninnetta; 2023 [cited 2024 Apr 02]. Available from:
https://myrillaotori.pages.dev/wpavb-uk-and-great-britain-map-ggkap-photos/
6. Medicines and Healthcare products Regulatory Agency. “Rolling review for marketing authorisation applications” [Internet]. gov.uk;2024 Apr 16 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/rolling-review-for-marketing-authorisation-applications
7. Medicines and Healthcare products Regulatory Agency. “European Commission (EC) decision reliance procedure” [Internet]. gov.uk;2022 Nov 18 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure
8. Medicines and Healthcare products Regulatory Agency. Decentralised and mutual recognition reliance procedure for marketing authorisations [Internet]. gov.uk;2021 Feb 23 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations
9. Medicines and Healthcare products Regulatory Agency. “Unfettered Access Procedure for marketing authorisations approved in Northern Ireland” [Internet]. gov.uk;2024 Jan 05 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/unfettered-access-procedure-for-marketing-authorisations-approved-in-northern-ireland
10. Medicines and Healthcare products Regulatory Agency. “Project Orbis” [Internet]. gov.uk; 2024 Jan 12 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/guidance-on-project-orbis
11. Medicines and Healthcare products Regulatory Agency. “Access Consortium” [Internet]. gov.uk; 2024 Feb 26 [cited 2024 Apr 02]. Available from:
https://www.gov.uk/guidance/access-consortium
12. Medicines and Healthcare products Regulatory Agency. “Apply for a licence to market a medicine in the UK” [Internet]. gov.uk;2024 May 14 [cited 2024 May 30]. Available from:
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#fast-track-your-marketing-authorisation
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