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European Regulatory Roundup: Brexit Czar Plans 'Standardized' Approval Processes After Leaving EU (13 October 2016)

Posted 13 October 2016 | By Nick Paul Taylor 

European Regulatory Roundup: Brexit Czar Plans 'Standardized' Approval Processes After Leaving EU (13 October 2016)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Britain's Brexit Czar Plans 'Standardized' Approval Processes After Leaving EU

The politician in charge of negotiating the United Kingdom's exit from the European Union has said he will seek to get "standardized" approval processes. David Davis made the comment in response to concerns raised by AstraZeneca CEO Pascal Soriot about the effect of Brexit on how long it takes the UK to access to new drugs and how much they cost.

Talking to The Sunday Times, Soriot said drugmakers prioritize getting their products approved in the United States, Europe, China and Japan. As a member of the European Union, the UK is among the first countries to gain access to new medicines, if it agrees to pay for them. However, if the UK sets up its own drug approval system upon leaving the EU, Soriot thinks it will fall down the pecking order. The CEO envisions the UK joining Australia and Canada in the second wave of nations to gain access to new drugs. Also, if the new system increases AstraZeneca's costs, it will raise its prices in the UK.

Daniel Zeichner, a politician in the opposition who represents the biopharma hotspot of Cambridge, put Soriot's comments to Davis during a debate on leaving the EU. Specifically, Zeichner asked Davis if Soriot was right to say the absence of a common approval process with the EU would increase the cost of drugs to the National Health Service. While sidestepping the question, Davis revealed a clue about how he foresees the drug approval process working if the UK leaves the EU as expected in 2019.

"I am not in a position to do those sums for the honorable gentleman, but I will tell him that that is one of the things that we will seek to get standardized," Davis said. In keeping with the government's resistance to saying more about its Brexit strategy than is absolutely necessary, Davis gave no further details, opting instead for a vague statement about the importance of life sciences. "There will be a number of areas such as life sciences where we have a big interest. We are, after all, the largest life science centre in Europe, so that will be front and center of our negotiations," he said.

Zeichner's question was one of two about the future of the pharmaceutical sector post-Brexit that politicians put to Davis during the debate. The other came from a politician representing part of the city of Liverpool in which Eli Lilly has a manufacturing plant. In response to a request for reassurance about the future of the drug sector, Davis said: "I do not think the pharmaceutical industry is running away from this country — just the reverse." Davis cited a post-referendum investment commitment from GlaxoSmithKline to support his case, before giving his take on why drugmakers are in the UK.

"The pharmaceutical industry is predominantly in the UK for reasons that relate to intellectual property among other things," he said.

This week also saw a small group of UK politicians meet to discuss the future of the European Medicines Agency (EMA). However, as Davis and other politicians involved in making Brexit happen were in a separate, broader discussion of the split at the same time, little, if anything, conclusive was said.

"I have no idea how [EMA's location] will end up," David Mowat, a politician involved with the Department of Health, said. "For me to say it is an absolute line in the sand that the EMA must stay in the UK would be a nonsense."

Debate Transcript, The Sunday Times,More

EMA Moves to Clarify GMP Responsibilities of MAHs, Contract Manufacturers

EMA is planning to collate the good manufacturing practices (GMP) that relate to marketing authorization holders (MAHs) to clarify who is responsible for what tasks. EMA thinks such a document is needed to centralize disparate information regarding the roles of MAHs and contract manufacturers.

Members of the GMP/GDP Inspectors Working Group made their case for a central document, which would take the form of a reflection paper, in a draft concept paper. In the concept paper, the working group sets out the perceived shortcomings of the current system and how the creation of a reflection paper would make life easier for MAHs, manufacturers, GMP inspectors and other groups involved in ensuring the quality of pharmaceuticals. The idea is not to create additional responsibilities. Rather, EMA wants to clarify the intent of its existing regulations.

"The way in which MAHs are expected to interact with the manufacturing sites registered in a marketing authorization is not sufficiently clear," EMA wrote. "Some MAHs are not clear on their responsibilities. When MAHs and manufacturers are different companies and/or separate legal entities, it becomes increasingly important to clearly define the role of the MAH in facilitating GMP compliance at outsourced manufacturing and control organizations. Furthermore, certain important activities of MAHs with respect to ensuring GMP and MA compliance are not well addressed."

The concept paper highlights approximately 10 specific sections of regulatory documents that relate to the GMP responsibilities of MAHs. Some of these are sources of confusion. For example, chapter one of the EC Guide to GMP tasks MAHs with evaluating the results of product quality reviews and assessing whether corrective or preventative actions are needed. This is true regardless of whether the MAH or a contract manufacturer produced the drug. Yet, in EMA's experience, MAHs are failing to evaluate the quality reviews.

EMA has given industry until the end of November to comment on its concept paper. Once the comments are in, a drafting group will start work on a reflection paper. The aim is to agree upon a reflection paper by June 2017.

Concept Paper

EMA Creates Checklists to Guide MAHs Through Renewal Processes

EMA has released three pre-submission checklists to help MAHs with various renewals. The texts detail the information MAHs need to include when filing annual reassessments, five-year renewals and submissions related to conditional marketing authorizations.

Each document includes a table detailing the information MAHs need to provide, a checkbox to tick once they have met the requirement and comments to expand on and clarify what EMA wants. The checklist for five-year renewal applications, for example, instructs MAHs to include a cover letter, details of the qualified person, a recent certificate of GMP compliance and other information in their submissions.

MAHs going through the other renewal processes must provide a slightly different set of information, both from each other and their peers going through the five-year pathway. MAHs with conditional approvals and those granted under exceptional circumstances may need to provide clinical study reports to meet specific obligations detailed at the time of the approval. These reports are needed to meet post-approval obligations to demonstrate the safety and efficacy of the drug.

The checklists do not place additional requirements upon MAHs going through the various renewal processes. Rather, the checklists are designed to help MAHs ensure they include all the necessary information in their filings.

Annual Checklist, Five-Year Checklist, Conditional Checklist

Other News:

The Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the approval of a drug to protect honeybees from parasites. CVMP made the decision on the drug from BeeVital at its October meeting. Press Release, More


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