UK Marketing Authorisation Holders (MAH) should be reviewing their manufacturing processes to identify and diminish any risk of the presence of nitrosamine impurities in their medicines. Read more “Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?”
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
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”