RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > European Regulatory Roundup: Import Guidance Coming; Ombudsman Probes Trial Transparency (4 June 201

European Regulatory Roundup: Import Guidance Coming Ombudsman Probes Trial Transparency (4 June 2015)

Posted 04 June 2015 | By Nick Paul Taylor 

European Regulatory Roundup: Import Guidance Coming Ombudsman Probes Trial Transparency (4 June 2015)

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

Offshoring of Production Prompts EMA to Work on Guidance for Importers

The European Medicines Agency (EMA) has released a concept paper outlining its plans to draft guidelines for importers of medical products. EMA is working on the guidelines in response to the rising proportion of drugs sold in the European Union that are manufactured outside the region. 

Officials at the Good Manufacturing Practice (GMP)/ Good Distribution Practice (GDP) Inspectors Working Group have set themselves a target of January 2016 for the publication of the first draft of the guidelines, which will address gaps in the current regulatory framework. Specifically, EMA wants to create a new annex to clarify how existing GMPs apply to importers of medical products. Such clarifications are needed as most GMP noncompliance reports uploaded to EMA’s systems relate to foreign plants.

The planned annex will start by defining the term “import,” a word EMA thinks is complex given the global nature of supply chains today. EMA also wants to communicate knowledge it has gained since the 2013 revision of the “Union Format for Manufacturer’s Authorisation.” The quality systems, staffing and buildings operated by importers are affected by the requirements laid out in the document.

Exactly how this manifests varies from importer to importer, and EMA will address this in the planned annex. The concept paper released this week is open for consultation until 29 August, at which time EMA will start discussing a draft annex internally. EMA is aiming to share the document publicly for consultation in January and have a final draft ready by November 2016.

Concept Paper

Ombudsman Probes Development of Clinical Trial Regulation in Transparency Assessment

European Ombudsman Emily O’Reilly has begun an investigation into the transparency of informal legislative negotiations between the European Parliament, the Council and the Commission. The probe will look at negotiations over two laws, one of which is the Clinical Trial Regulation.

O’Reilly wants to inspect all the files generated in informal negotiations between the three bodies over the trial regulations. Such negotiations, which are known as trilogues, are commonplace in the European legislative machinery but, in O’Reilly’s view, may be too secretive to comply with transparency requirements. The concerns center on O’Reilly’s inability to find a full, public list of ongoing trilogues or a complete record of the documents shared at the meetings.

With an estimated 1,500 trilogues taking place over the past five years, around 80% of European Union laws are now agreed at a first reading, a trend that has shifted negotiations away from public forums. O’Reilly has decided to focus on the now-closed negotiations over the Clinical Trial Regulation and Mortgage Credit Directive. The Ombudsman is expecting a reply to her list of questions and request for access to the Clinical Trial Regulation files by the end of September

Press Release, Ombudsman Letter

EMA Posts Flurry of Guidelines on Human-Plasma Derived Products

EMA has published a flurry of guidelines relating to human-plasma derived products, including its final position on clinical trials of factor IX treatments and draft documents relating to factor VIII. The draft factor VIII guidelines cover clinical trials and labeling of the class of hemophilia A drugs.

Officials at EMA drafted the guidelines to address the specific characteristics and requirements of recombinant or human plasma-derived factor VIII products. In terms of the Summary of Product Characteristics (SmPC), these unique features manifest in the need to list dosing regimens for the varying severities of hemorrhage and surgical procedures experienced by people with hemophilia A. Requirements for recombinant therapies differ from those for plasma-derived products.

The SmPC draft is intended to be used in conjunction with the second document on factor VIII released by EMA this week, in which the regulator details how developers should approach clinical trials. The enrollment of previously treated patients to cut the risk of inhibitor formation-related side effects, prevention of viral contamination and need for post-marketing studies are covered in the draft. EMA has opened the draft guidelines up for comment until July 1. 

EMA’s Committee for Medicinal Products for Human Use also signed off on final guidelines on the clinical development of factor IX products for treating hemophilia B. The document covers many of the same topics as the draft factor XIII guidelines and is due to come into force in September.

Factor IX Guidelines, SmPC Draft, Factor VIII Draft

Herbal Medicine Quality Guidelines Enter Revision Process

EMA’s Quality Drafting Group has posted two concept papers on the quality of herbal medicines. The documents cover the need to update the existing quality and testing guidelines in response to revisions to the European Pharmacopoeia “Herbal Drug Extracts” monograph and other changes.

Both sets of guidelines were last updated in 2011, since when EMA has gained knowledge about the topics and related regulatory documents have evolved. The regulator cites changes to multiple documents such as the “Guideline on declaration of herbal substances and herbal preparations in HMPs/THMPs” and an associated question and answer document in its justification for starting work on revising the guidelines.

Specific details of what EMA wants to change are yet to emerge, but the general idea is to bring its guidelines on the testing procedures and quality of herbal medicines in line with current thinking and regulations. EMA is accepting comments on the documents until 31 August and is aiming to make draft guidelines available within six months of the adoption of the final concept papers.

Quality Concept Paper, Testing Concept Paper

Other News:

Bulgaria and Romania have agreed to jointly negotiate drug prices with pharma companies. The alliance, which mirrors a decision made by Belgium and the Netherlands, is intended to increase the buying power of Bulgaria and Romania and in doing so drive down the per-unit price the neighboring countries pay. The partners are open to other countries joining the alliance. Politico

EMA’s Quality Review of Documents (QRD) group has updated its recommendations on seeking exemptions to product labeling requirements. The update covers what happens with generics when their innovator reference product has already been granted an exemption. QRD also released an updated list of its responses to exemption requests. Recommendations, Responses

Health officials in Russia have responded to a spate of suicides by cancer patients in Moscow. The trend is thought to relate to the difficulties patients have in sourcing pain medications. Anyone who is unable to source morphine or other painkillers is being urged to contact the health ministry directly to resolve their supply problem. AP

EMA has released another update to its pre-authorization procedural advice for users of the centralized procedure. The latest additions cover how to handle a change in the anticipated date of a submission, requesting a meeting with rapporteurs to discuss the committee’s questions and the process for oral explanations. EMA Advice

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed it will move fully to the common repository for centralized procedures from next month. Centralized submissions sent to MHRA after July 1 will not be processed. The move is part of a Europe-wide shift to complete reliance on the common repository. MHRA Notice

George Freeman, the United Kingdom minister for life sciences, has said the government has no plans to create a New Medicines Fund covering England. In October, Scotland outlined plans to create a $60 million fund to increase access to new medicines. Hansard

Regulatory Focus newsletters

All the biggest regulatory news and happenings.