This article is about the EU MDR Regulation – Medicines and Healthcare Products Regulatory Agency (MHRA) announcing that the UK will be the first country to introduce a tailored framework for the regulation of innovative patient care products. As per EU MDR Regulation – This makes it easier to make highly individualized drugs and new drugs with a very short shelf life in a hospital environment or close to an emergency room, and they get to those who need them much faster.
The new framework guarantees that there are no legal barriers to creative manufacturing and that products made in this way are as safe, high quality and efficient as products made using more traditional manufacturing methods. This comes after the MHRA held a public consultation involving a number of people and organizations from the UK and abroad. Describing experiences with Point of Care (POC) products, respondents emphasized the urgent need to develop a regulatory framework for these important and diverse purposes.
A number of advantages might result from the creation of a regulatory framework for POC production, including:
- Patients and carers will benefit from quicker access to innovative therapies, reducing travel and hospital time.
- Medical professionals strive to provide more efficient treatments and improve patient compliance.
- Entrepreneurs should simplify product creation and set clear regulatory requirements.
The MHRA will introduce legislation to amend the UK Human Medicines and Clinical Trials Act and produce guidelines in line with the new framework. Work has begun with other authorities in the UK and abroad to create an equivalent regulatory regime.
Subscribe to our MORULAA website to receive the latest medical news from around the world and get in touch with our MORULAA advisors for help with the regulatory compliance in India and in Southeast Asia.
Source – Medical Products Regulation Agency of the United Kingdom
