Quality
Generic and biosimilar medicines in the UK must comply with exactly the same standards of quality, safety and efficacy as all medicinal products. They are produced in plants regularly inspected by the MHRA, the UK medicines regulator. Just like originator products, once a generic medicine is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported.
Quality Forum
Medicines UK runs a Quality Forum in conjunction with the MHRA to focus on issues and guidance relating to quality. The group meets three times a year to share and discuss the latest information which impacts quality in the generics industry, from auditing and inspections through to data integrity and issues surrounding active pharmaceutical ingredients.
A collaborative and partner-focused relationship between industry and the regulator is extremely beneficial in terms of building trust and mutual understanding of challenges and opportunities in the off-patent sector.
As well as the Quality Forum, we also have a range of other regular touchpoints with the MHRA to ensure our members understand the evolving regulatory landscape.
Regulatory engagement
The MHRA rightly has a strong and positive reputation among its peers for its contribution and scientific expertise.
In the key area of new product registrations, Medicines UK has been closely surveying the MHRA's performance year on year and identifying areas requiring improvement for discussion with the regulator.
This has resulted in a major improvement in the time taken for new generic and biosimilar medicines to be registered in the UK. This is greatly assisting the predictable, timely availability of off-patent medicines for patients and healthcare professionals and has also resulted in NHS cost savings.
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