Category: MHRA

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency

MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit

Posted at 17:10 on October 23rd, 2019 in Brexit, Medicinal product, MHRA, Trials

In the event of a no-deal Brexit, reference medicinal products (RMP) for new generic medicines or abridged marketing authorisation applications will be required to comply with the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs). Comparator products (CP) used in these applications will need to be representative of the RMP. Read more “MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit” →