Regulatory Focus™ > News Articles > 2020 > 10 > Euro Roundup: MHRA shares post-Brexit assessment routes, variations guidances

Euro Roundup: MHRA shares post-Brexit assessment routes, variations guidances

Posted 29 October 2020 | By Nick Paul Taylor 

Euro Roundup: MHRA shares post-Brexit assessment routes, variations guidances

New guidances from the Medicines and Healthcare products Regulatory Agency (MHRA) address new assessment routes, marketing variation processes and rules on converting Community Marketing Authorisations (CAPs) that will apply to products sold in the United Kingdom post-Brexit.
 
The new assessment routes include an accelerated assessment pathway that, like its EMA equivalent, will reduce the regulatory review timeline to 150 days, according to the guidance.
 
The pathway is open to “good quality new marketing authorization applications for both new and existing active substances and submitted directly to UK.” Requests for conditional and full approval, as well as applications for authorization under exceptional circumstances, are eligible. MHRA plans to initially adopt EMA technical guidance on conditional and exceptional marketing authorizations.
 
MHRA also is creating processes more tailored to the UK. For example, MHRA is developing a “new medicine designation that links to the development of a roadmap to patient access in the UK healthcare system.” In practice, the plan will result in an integrated pathway intended to enable drug developers to access input from MHRA and other bodies including the National Institute for Health and Care Excellence (NICE).
 
The pathway could address one of the shortcomings of the European system – a disconnect between the marketing authorization and health technology assessment processes. By involving MHRA and NICE, the UK could make it easier for drug developers to get feedback on the evidence they will need to satisfy the demands of both agencies.
 
MHRA’s guidance on new assessment routes also addresses rolling reviews. The approach, like EMA’s equivalent, enables drug developers to submit data as it becomes available, rather than waiting until all the evidence is generated. The phased approach can cut the time it takes to approve a drug once all the evidence is available.
 
Separately, MHRA said it will adopt European Commission decisions on the approval of new marketing authorizations in the community marketing authorisation procedure until the end of 2022. MHRA is asking companies to send it all the information included in applications to EMA once the Committee for Medicinal Products for Human Use (CHMP) has issued its opinion.
 
MHRA also shared guidance on the conversion of CAPs to Great Britain Marketing Authorizations (MAs). As previously disclosed, MHRA will automatically convert CAPs to MAs at the start of next year. MHRA is asking CAP holders to check if all their products are covered by its plans and tell it if they do not want to convert any authorizations to MAs.
 
The third guidance document released by MHRA this week details how the agency will handle variations to MAs after Brexit. The UK will incorporate EU policy on variations to national MAs into its law at the end of the year. MHRA will automatically recognize Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) recommendations on variations posted before the year. However, any applications pending a CMDh decision as of January will need to be re-sent to MHRA.
 
Assessment Routes, MA Variations, CAP Conversions
 
Swissmedic finds nitrosamine in TB drugs, spurring EU-wide probe
 
The Swiss Agency for Therapeutic Products (Swissmedic) has discovered a nitrosamine in tuberculosis drugs containing the active substance rifampicin, triggering an EU-wide investigation into the report.
 
Testing by Swissmedic’s laboratory found a new nitrosamine impurity, 1-nitroso-4 methyl piperazine (MeNP), in batches of rifampicin active ingredients and finished products sold in Switzerland. MeNP was found in all products on the Swiss market. Swissmedic has defined 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 has shared its test results with EMA and the European Directorate for the Quality of Medicines. CMDh said it is liaising with the companies involved and working to ensure their products undergo adequate testing.
 
Products containing rifampicin are supplied in Europe by Mylan, Sanofi and other manufacturers.
 
Swissmedic Notice, CMDh Notice
 
MHRA clears unlicensed Sanofi flu vaccine to boost supplies
 
MHRA has granted a temporary authorization to Sanofi’s seasonal influenza vaccine Flublok, making the FDA-approved vaccine available in the UK to meet high demand.
 
Flublok was first approved in the US in 2016 and has been given to 9 million people so far. It has not been approved in the UK or EU, although CHMP recommended its quadrivalent sibling Supemtek last month.
 
MHRA compared Supemtek and Flublok before granting Sanofi temporary authorization, concluding “the two products are fundamentally similar on the basis of a review of the manufacture, control, quality, non-clinical and clinical evaluation.” UK scientific advisory body the Commission on Human Medicines agreed with that conclusions.
 
The temporary authorization comes shortly after the UK government allowed pharmacists to administer unlicensed vaccines. Granting that power to pharmacists and temporarily authorizing Flublok form part of the UK’s efforts to run its largest ever vaccination program against seasonal influenza.
 
MHRA Notice
 
CMDh elects MEB’s Kora Doorduyn-van der Stoep as next chair
 
CMDh has elected Kora Doorduyn-van der Stoep as its next chair. Doorduyn-van der Stoep, who has worked at the Dutch Medicines Evaluation Board (MEB) for 30 years, will take up the position in November.
 
Currently, Doorduyn-van der Stoep is the vice chair of CMDh, serving under the Spanish Agency for Medicines and Medical Devices’ Laura Oliveira Santamaria. That is set to change next month when Doorduyn-van der Stoep, who was elected by an absolute majority of CMDh members, will start her three-year spell as chair of the organization.
 
Doorduyn-van der Stoep joined MEB in 1986 and has been involved with CMDh since 2010. In her role at CMDh, Doorduyn-van der Stoep has coordinated an initiative to harmonize risk-management plans.
 
CMDh Notice, MEB Notice (Dutch)
 
Other News:
 
The French National Agency for Medicines and Health Products Safety (ANSM) has rejected a request to use hydroxychloroquine in the management of COVID-19. The request came from the hospital where Didier Raoult, the microbiologist who established hydroxychloroquine as a potential COVID-19 treatment, works. ANSM sees uncertain benefits and clear risks associated with the medicine. ANSM Notice (French) 
 
EMA has shared data on the continued decline of veterinary antibiotic use in the European Union. Sales fell more than 34% between 2011 and 2018, driven by steep declines in the use of polymyxins and certain quinolones. EMA Statement

 

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