New guidelines from the Medicines and Health Products Regulatory Agency (MHRA) address new avenues for assessment, marketing modification processes and rules on the conversion of Community Marketing Authorizations (CAPs). ) which will apply to products sold in the UK after Brexit.
The new assessment routes include an accelerated assessment route which, like its EMA counterpart, will reduce the regulatory review time to 150 days, according to the guidelines.
The way is open for ‘new good quality marketing authorization applications for new and existing active substances submitted directly to the UK’. Requests for conditional and full approval, as well as requests for authorization in exceptional circumstances, are eligible. The MHRA plans to adopt the EMA’s technical guidelines on conditional and exceptional marketing authorizations as a first step.
MHRA is also creating more suitable processes in the UK. For example, MHRA is in the process of developing a ‘new drug designation which is linked to the development of a roadmap for patient access in the UK healthcare system. In practice, the plan will translate into an integrated pathway for drug developers to access contributions from the MHRA and other organizations, including the National Institute for Excellence in Health and Care (NICE ).
The path could fill one of the gaps in the European system – a disconnect between the marketing authorization and health technology assessment processes. By combining MHRA and NICE, the UK could make it easier for drug developers to get feedback on the evidence they will need to meet the demands of both agencies.
The MHRA’s guidance on new assessment pathways also covers ongoing reviews. The approach, like the equivalent of the EMA, allows drug developers to submit data as it becomes available, rather than waiting for all the evidence to be generated. The phased approach can reduce the time it takes to approve a drug once all the evidence is available.
Separately, the MHRA has stated that it will adopt the decisions of the European Commission on the approval of new marketing authorizations under the Community Marketing Authorization procedure until the end of 2022. The MHRA asks companies to send it all the information included in the requests to the EMA once the Committee for Medicinal Products for Human Use (CHMP) has delivered its opinion.
The MHRA also shared advice on converting CAPs into UK Marketing Authorizations (MAs). As previously stated, the MHRA will automatically convert CAPs to AMs at the start of next year. The MHRA asks CAP holders to check if all their products are covered by its plans and to tell them if they do not wish to convert the authorizations into MA.
The third guidance document released by the MHRA this week details how the agency will deal with variations in MAs after Brexit. The UK will incorporate the EU’s policy on domestic MA variations into its legislation at the end of the year. MHRA will automatically recognize the recommendations of the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) on variations posted before the year. However, any request pending a decision from the CMDh from January will have to be returned to the MHRA.
Assessment routes, MA variations, CAP conversions
Swissmedic finds nitrosamine in anti-tuberculosis drugs, sparks EU-wide investigation
The Swiss Agency for Therapeutic Products (Swissmedic) discovered a nitrosamine in anti-tuberculosis drugs containing the active substance rifampicin, triggering a European-wide investigation into the report.
Tests carried out by the Swissmedic laboratory revealed a new nitrosamine impurity, 1-nitroso-4 methyl piperazine (MeNP), in batches of active ingredients of rifampicin and in finished products sold in Switzerland. MeNP has been found in all products on the Swiss market. Swissmedic has set a temporary limit and sees no immediate risk to patient safety.
Rifampicin is a first-line treatment for serious infections, including tuberculosis and leprosy. Swissmedic said the risks of not taking rifampicin far outweigh the dangers posed by the contaminant in the target population.
Swissmedic shared the results of its tests with the EMA and the European Directorate for the Quality of Medicines. CMDh said it is liaising with the companies involved and working to make sure their products pass proper testing.
Products containing rifampicin are supplied in Europe by Mylan, Sanofi and other manufacturers.
Swissmedic Opinion, CMDh Opinion
MHRA clears unauthorized Sanofi influenza vaccine to boost supplies
The MHRA has granted temporary clearance for Sanofi’s Flublok seasonal influenza vaccine, making the FDA-approved vaccine available in the UK to meet strong demand.
Flublok was first approved in the United States in 2016 and has been offered to 9 million people to date. It has not been approved in the UK or the EU, although the CHMP recommended its quadrivalent brother Supemtek last month.
MHRA compared Supemtek and Flublok before granting Sanofi temporary clearance, concluding that “the two products are fundamentally similar based on a review of manufacturing, control, quality, non-clinical and clinical evaluations . ” The UK’s scientific advisory body, the Commission for Medicinal Products for Human Use, endorsed these findings.
The temporary authorization comes shortly after the UK government allowed pharmacists to administer vaccines without a license. Granting that power to pharmacists and temporarily authorizing Flublok is part of the UK’s efforts to implement its largest seasonal flu vaccination program.
CMDh elects Kora Doorduyn-van der Stoep from MEB as next president
CMDh elected Kora Doorduyn-van der Stoep as its next president. Doorduyn-van der Stoep, who worked at the Dutch Medicines Evaluation Board (MEB) for 30 years, will take up his post in November.
Currently, Doorduyn-van der Stoep is the Vice-President of CMDh, under the leadership of Laura Oliveira Santamaria of the Spanish Agency for Medicines and Medical Devices. That is set to change next month when Doorduyn-van der Stoep, who was elected by an absolute majority of CMDh members, begins her three-year term as president of the organization.
Doorduyn-van der Stoep joined the MEB in 1986 and has been involved with CMDh since 2010. In her role at CMDh, Doorduyn-van der Stoep coordinated an initiative to harmonize risk management plans.
CMDh Notice, MEB Notice (Dutch)
The National Agency for the Safety of Medicines and Health Products (ANSM) has rejected a request for the use of hydroxychloroquine in the management of COVID-19. The request came from the hospital where Didier Raoult, the microbiologist who established hydroxychloroquine as a potential treatment against COVID-19, works. The ANSM sees uncertain benefits and clear risks associated with the drug. ANSM Notice (French)
The EMA shared data on the continuing decline in the use of veterinary antibiotics in the European Union. Sales fell by more than 34% between 2011 and 2018, driven by sharp declines in the use of polymyxins and certain quinolones. EMA statement