Another year has drawn to a close and what an eventful year it has been for the regulators! Both the EMA and MHRA were involved in many due diligence activities. We look back at some of those key initiatives. There were some exciting developments within the EMA as it continues its drive towards a more consumer friendly and transparent organisation. In March the EMA launched PRIME (PRIority MEdicines), the new scheme to expedite review of drugs that address an unmet medical need. Applications for cancer, Alzheimer’s disease and antimicrobial drugs will also benefit from this scheme as there are few treatment options for these diseases. Statistics from the last EMA board meeting in October 2016 announced the scheme a success.
In June, the PSUR repository went live, allowing submission of the PSUR to a single recipient only, rather than multiple competent authorities. It also ensures timely assessment of the PSUR by the CAs and the EMA by providing the all relevant documents in one secure area, thus streamlining the review process.
The Medical Literature Monitoring service was launched in September covering 300 chemical active substance groups and 100 active substance groups. The Agency now performs the literature monitoring for these substances rather than the MAHs. However, for those substances not on the list, the MAHs will continue to review and report any ADRs to the Agency. The objective of the MLM is to increase efficiency of reporting adverse reactions and avoid duplication in reporting such reactions, as well as supporting signal detection activities for national competent authorities.