European Regulatory Roundup: EMA Outlines Support for Sponsors (30 April 2015)

Regulatory NewsRegulatory News | 30 April 2015 |  By 

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

EMA Outlines how MA Applicants can Access Regulatory Support

The European Medicines Agency (EMA) has updated a Q&A document to explain the role of its product teams and who is the regulatory contact for marketing authorization (MA) applicants. Posting the updates clarifies the support applicants can expect to receive and how they can access these resources.

EMA outlined its position on the topics by adding new questions to its pre-authorization advice on the centralized procedure. The first of the new questions covers the role of EMA product teams, the groups the regulator sets up to support the evaluation of each product submitted to the centralized approval pathway. Applicants can expect the EMA team to help with the technical preparation and validation of their submissions.

Each team includes a procedure manager (PM), who acts as the link between an applicant and EMA during the pre-submission phase. EMA is encouraging applicants to approach their PM — the name and contact details of whom are shared in the eligibility outcome letter — with any questions about the evaluation procedure. Applicants can also expect to be contacted by the EMA product lead (EPL) throughout the process.

EPLs help applicants with aspects of the scientific evaluation, such as how to prepare for clarification meetings and what will be expected of them during oral explanations. EMA went into greater detail on the oral explanation process in a guidance document published last week.

Q&A Document  

EDQM and USP Scrap Monograph Harmonization Project

The European Directorate for the Quality of Medicines and Healthcare (EDQM) and the United States Pharmacopeial Convention (USP) have jointly decided to stop a harmonization pilot project. EDQM and USP made the decision after encountering “complexities” when trying to align their processes.

EDQM started the project in 2008 to drive development of harmonized monographs and reference standards for patent-protected drug substances. Merck and Pfizer gave identical dossiers to EDQM and USP covering the active ingredients in four of their drugs — namely Celebrex, Maxalt, Singulair and Viagra — and laboratories at both of the standards-setting organizations verified the methods.

The work led to the adoption of four monographs synchronized between the European and US pharmacopoeias. EDQM and USP also established 11 reference standards in support of the four monographs. However, efforts to align the processes of EDQM and USP “revealed complexities” that raised doubts about the value of the initiative.

“[It] ultimately did not provide added value to the harmonized standards published,” the groups wrote in a press release. The realization prompted EDQM and USP to end the collaboration. Both groups intend to continue collaborating on prospectively harmonized monographs but “in a less formal manner.”

Press Release

HMA, EMA Post Draft Addition to Good Pharmacovigilance Practices

The Heads of Medicines Agencies (HMA) and EMA have published a draft addendum to guidelines on good pharmacovigilance practices (GVPs) explaining their stance on using educational programs to minimize risk.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) can recommend the use of such programs — which go beyond the standard summary product characteristics (SmPC) and package leaflet (PL) — as a condition of marketing authorizations. When products are approved with such a stipulation, key elements or the exact content of the materials are agreed to at a European Union level before being passed on to member states or incorporated into the SmPC and PL.

The draft addendum to the GVP guidelines covers this whole process, from the purposes for which educational programs are mandated through to their publication on dedicated websites. Within this workflow, HMA and EMA explain the process for the submission and review of educational materials, as well as the format and content the regulators expect. The draft is open for comments until June 30 and is expected to come into force before the end of the year.

Draft Guidelines 

EMA Updates 28-Year-Old Active Substance Guidelines

EMA has published a line-by-line guide to the information manufacturers of active substances must provide. The draft guidelines outline what is expected of manufacturers, from the structure and properties of the ingredient through to details of stability tests and the data they generate. 

Members of the Quality Working Party put together the draft to replace a pair of old documents on the chemistry of active substances. One of the guidance documents dates back to 1987 and as such predates the common technical document, ICH Q11 and multiple other developments of relevance to active substance manufacturers. Combining the documents is also intended to make it easier for manufacturers to understand their obligations.

The new draft covers many of the same topics as the earlier documents but brings them up to date. For example, the discussion of active starting materials now refers readers to the requirements set out in ICH Q11 and adds a request that manufacturers share a full description of the synthetic steps that ensure active substance quality. EMA is accepting feedback on the draft until 24 October.

Draft Guideline 

Cardiac Side Effects Prompt EMA to Post Warning About Hepatitis C Drugs

EMA has recommended against using hepatitis C drugs from Bristol-Myers Squibb and Gilead in combination with the irregular heartbeat medicine amiodarone. The advice follows reports on both side of the Atlantic linking the combination to heart block and severe bradycardia.

In light of the reports, EMA recommends amiodarone only be given alongside Gilead’s Harvoni or a combination of the same company’s Sovaldi and Bristol’s Daklinza when no other antiarrhythmic can be used. When amiodarone must be administered, EMA wants physicians to closely monitor patients. Such care is needed even if a patient stopped taking amiodarone months ago because of the length of time it stays in the body.

The recommendations come one month after the United States Food and Drug Administration (FDA) made a similar statement. EMA reviewed eight reports of adverse events before making its decision. One case involved a fatal cardiac arrest while another two necessitated intervention with a pacemaker.

Press Release 

Other News:

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) is hosting a conference on how to file an abridged marketing authorization application. MHRA is holding the event to explain the best way to compile a dossier, the benefits of scientific advice meetings and its recently introduced fees calculator. MHRA Notice

EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 11 medicines, including Bristol-Myers Squibb’s melanoma treatment Opdivo and Vanda Pharmaceuticals’ sleep disorder drug Hetlioz. CHMP issued a negative opinion against Biovest’s Lympreva because of doubts about its benefits. Press Release, Lympreva Rejection

MHRA has shared an alert from Invacare about Birdie mobile hoists. Invacare has introduced a lockable carabiner and revised instructions for the hoists in response to a small number of reports of faults with the old design. The lockable carabiner is available to any user with a hoist manufactured before 1 March. MHRA Notice

The run up to the general election in the United Kingdom has sparked a flurry of debate about the future of the National Institute for Health and Care Excellence (NICE) and market access. Some are calling for NICE to drop its quality-adjusted life years (QALY)-based methods, while others think it needs to keep the metric but raise the threshold. PMLiVE, OnMedica, More


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