The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposed changes to its fee structure, which include increasing its medicines regulation fees by 2.8%.
It is also proposing an additional 5% increase in periodic fees to cover pharmacovigilance activities, some of which will in future be covered by fees charged by the European Medicines Agency (EMA).Overall, the consultation concerns plans to introduce some new fees, simplify others and increase some fee levels charged by the Agency for regulation of medicines. The intention is to revoke the Medicines (Products for Human Use) (Fees) Regulations 2012 (SI 2012/504) and remake with amendments to provide a single comprehensive set of regulations.
The proposed measures, which aim to simplify the fee structure further whilst ensuring full cost recovery, also include:
- simplifying clinical trial (CT) fees by removing the standard CT service fees and introducing two application fees and one standard variation fee that also covers medical variations (protocol amendments);
- simplifying the current structure of fees for new sources/suppliers of simple substances also serving as active pharmaceutical ingredients (APIs). Standard fees, rather than complex fees, would be charged to new suppliers of a defined set of these simple substances;
- introducing a routine programme of stand-alone pharmacovigilance inspections of service providers in the UK, for which a fee would be levied. Currently, one service provider which provides a service to several marketing authorisation holders (MAHs) will be inspected on multiple occasions, but the proposed change will mean that they would only be inspected once on a risk-based basis;
- introduce fees for application, inspection, variations and annual compliance for brokers and active substance manufacturers, importers and distributors, as a result of implementation of the Falsified Medicines Directive; and
- make changes to text relating to variations to purely UK national marketing authorisations (MA), resulting from implementation of the updated European variations Regulation 1234/2008/EC. This document replaces the need for separate national guidance, and the fees regulations need to reflect this.
The proposals set out in the consultation are designed, it says, to achieve: - for the industry, proportionate fees that enable the MHRA to respond efficiently and effectively; - for the Agency, a five-year plan that provides the resources which it expects to need; - further support for its "better regulation" agenda; - further transparency in the MHRA's fee proposals; and - simplified systems and more accessible law.