2015年1月26日 · How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom. 1. Overview. 2. Getting a classification...

With complexity and risk associated with each stage of assay development, our Advanced Therapy Medicinal Products (ATMP) best practice guidance offers a practical and phase-appropriate validation...

We have published new guidance in the BP 2022 to support users in applying and developing analytical methods. Advanced Therapy Medicinal Products Guidance: Application of Flow Cytometry. ATMPs...

With complexity and risk associated with each stage of assay development, our Advanced Therapy Medicinal Products (ATMP) Flow Cytometry and Vector Copy Number best practice guidance offers a...

In 2008 an ATMP-specific regulation came into force - Regulation 1394/2007 (‘The ATMP regulation’). MHRA regulates for both Northern Ireland (part of EU) and Great Britain (England, Wales, Scotland).

ABPI is a supportive partner of the Accelerated Access Collaborative (AAC) and has led the AAC’s ATMP Early Stage Product Workstream 3 to develop a roadmap that sets out the key steps and activities in the end-to-end pathway for ATMPs in England from non-clinical research through to patient treatment.

MHRA strategy - Pharmacopoeial Standards for Biological Medicines Work to achieve this strategy: • Engagement with wider community • Working to establish a specialised ATMP working party • Informal stakeholder workshop being developed to discuss standards and the most valuable areas to target

2025年3月9日 · To legally sell or supply an Advanced Therapy Medicinal Product (ATMP) in the United Kingdom, you must obtain a marketing authorisation (MA). This process ensures that the ATMP meets the required standards of safety, quality, and efficacy.

As with all investigational medicinal products, clinical trials for advanced therapy medicinal products (ATMPs) in the UK are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), within the framework of the Medicines for Human Use (Clinical Trials) Regulations 2004.

On 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK will be the first country in the world to introduce a tailored framework for the manufacture of innovative medicines at or close to the location where a patient receives care.