Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Prime Minister Calls for Lighter Biopharma Regulations
United Kingdom Prime Minister David Cameron is pushing for lighter regulations in an attempt to stop drug development being so “abhorrently expensive and time consuming.” Cameron’s office made the comments during a visit to Washington, DC to discuss Ebola with President Barack Obama, Bloomberg reports.
The fast-tracking of Ebola drugs and vaccines into clinical trials has shown that — in certain instances — it is possible to shorten development timelines. Cameron sees regulations and licensing processes as being among the factors stopping more therapies from advancing quickly out of laboratories and into real-world use.
An independent UK review into how to cut the time and cost of bringing new drugs to patients is due to report its findings in the summer. Separately, the role of the National Institute for Health and Care Excellence (NICE) and other UK health agencies is being reviewed. Cameron’s ability to enact any changes depends on the outcome of the election, which is being held in May.
EMA Outlines Thinking on Commercially Confidential Trial Details
The European Medicines Agency (EMA) has begun a public consultation on its new clinical trial portal and database. EMA is seeking feedback on a 28-page draft proposal, in which it details the ways it is considering implementing the transparency rules brought in by the European Clinical Trial Regulation.
Around one third of the document deals with the controversial topic of what information should be classed as commercially confidential and how it should be handled. More than 500 words are needed just to define “commercially confidential information.” EMA then goes into great detail about the various documents that can contain such information, including protocols and investigator brochures.
Throughout the document, EMA asks direct questions about whether readers agree with its proposals or think they comply with certain regulations. The industry has until 18 February to send answers to these questions and other pieces of feedback to EMA.
EMA Release I Draft Proposal | Regulatory Focus
CVMP Adopts Clutch of Guidance Documents and Reflection Papers
The Committee for Medicinal Products for Veterinary Use (CVMP) has started 2015 by adopting a clutch of regulatory documents, including a reflection paper on antimicrobial resistance and revised draft guidelines on vaccine contamination.
CVMP is due to publish the documents on the EMA website. The adopted reflection paper is a revised version of the document on antimicrobial resistance transfer from companion animals that CVMP released for public consultation in 2013. CVMP wrote the paper to address the risk of multidrug-resistant bacteria found in animals posing a threat to humans.
The committee also removed a provision about an in vivo test from its draft guidelines on the contamination of vaccines with bovine viral diarrhea virus and finalized its thinking on biocides in animal husbandry. CVMP dealt with a batch of marketing applications at the meeting, too.
CVMP Meeting Notes
MHRA Warns of Fault with Roche Insulin Pumps
A fault with Roche’s Accu-Chek Spirit Combo insulin pumps has underlined the new risks regulators will have to consider as electronic devices come to play a bigger role in healthcare. The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert about the pumps after receiving reports of the devices’ clocks resetting.
Some users reported the clocks on their devices reset after the batteries were changed. The resets may have resulted in devices delivering insulin outside their scheduled times. MHRA is recommending patients check their devices after a battery change or other power interruption to ensure they are working properly.
Such issues could become increasingly common as use of electronic devices — particularly those with connectivity capabilities — rises. Roche is replacing the faulty devices.
Press Release I MHRA Alert
Industry Feedback Prompts EMA to Share Generic Assessments
The EMA decision to share its assessments of generic drug marketing applications with some of its peers outside the European Union was partly motivated by feedback from industry, the regulator told in-PharmaTechnologist.
EMA began sharing its assessments with local regulators last year and is now expanding the pilot program to include Australia, Canada, Chinese Taipei and Switzerland. Other members of the International Generic Drug Regulators Pilot (IGDRP) — which includes Brazil, China and Japan — may join at a later date.
The addition of more regulators will depend on the wishes of other agencies and the industry, which played a role in this week’s expansion. Companies requested the move to cut some of the duplicated workload that is currently required to win approval in multiple markets.
in-PharmaTechnologist I Regulatory FocusI Press Release
EMA has published a guide to help companies in the region adopt new international standards for adverse event reporting. The guide covers what EMA will expect in terms of the electronic transmission, format and content of individual case safety reports once ISO ICSR comes into force in July 2016. EMA thinks the standard will improve safety report data quality. Press Release
The Association of the British Pharmaceutical Industry (ABPI) is pushing for the development of a system for value-based assessment to be put back on the agenda in the UK. Work on such a system stalled in the second half of 2014. PMLiVE
Takeda has recalled three batches of iron deficiency anemia treatment Rienso from the UK because the patient information, carton and vial label featured outdated information. The therapy is now administered by infusion, not injection. MHRA Alert
The Danish Health and Medicines Authority has reminded market authorization holders that ATC Codes have changed. Affected companies must request for the summary of product characteristics to be updated. Statement
MHRA has extended its statement of noncompliance against Wockhardt to cover all active pharmaceutical ingredients (APIs) manufactured by the Indian company. Wockhardt has already stopped supplying APIs to Europe. in-PharmaTechnologist
The European Food Safety Authority (EFSA) has ruled current levels of exposure to bisphenol A (BPA) pose no risk to people of any age. Studies have linked BPA — an endocrine-disrupting chemical used in plastics — to a range of illnesses. Reuters
PMLiVE has taken a look at the many issues facing Dr. Vytenis Andriukaitis, the recently appointed European health commissioner. Ebola and trade deals are two major items in Andriukaitis’ inbox. PMLiVE
The chair of the UK’s Cancer Drugs Fund (CDF) has admitted the body he leads has handed some pharma companies a “get-out-of-jail card for reimbursement.” The chair wants to improve the situation by working more closely with NICE. PMLiVE
EMA has updated its documents on pediatric investigation plans (PIPs) in response to changes to the European Commission’s guidelines. EMA Statement
MHRA has named Dr. Angela Thomas as vice-chair of the Commission on Human Medicines (CHM). CHM advises on drug safety, quality, adverse events and efficacy. MHRA Release
The European Commission has published an updated list of all of the standards — both current and obsolete — relating to active implantable medical devices. EC List
Russia’s Roszdravnadzor has adopted a new medical device classification system. The new model moves Russia closer to the Global Medical Device Nomenclature. Regulatory Focus
A clutch of trade groups have released a joint document outlining how to prevent drug shortages. The document was written in response to EMA’s call for voluntary action. Press Release
EMA is to start reviewing an application from Samsung Bioepis to sell a biosimilar version of Amgen’s rheumatoid arthritis drug Enbrel. Press Release