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A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. A searchable list of opinions/decisions on PIPs is available on this website.
A Periodic Safety Update Report (PSUR) is a document which provides an evaluation of the risk-benefit balance of the medicine at defined times following authorisation. A searchable list of the decisions taken as a result of the MHRA assessment of PSURs is available on this website.
MHRA-GMDP contains information relating to manufacturing and wholesale distribution authorisations, API registrations and GMP/GDP certificates.