Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU-Funded Report Documents Calls for Plasma Regulation Rethink
An independent report funded by the European Union has documented the blood plasma industry’s calls for regulatory changes. The proposed changes stem from frustrations about the growing size of clinical trials, a lack of global harmonization and the cautious attitudes of regulators to variant Creutzfeldt-Jakob disease (vCJD).
Consultancy Creativ Ceutical authored the report using money from the EU Health Programme, after which the European Commission added comments from stakeholders. The result is a 139-page paper that details the ways in which members of the plasma industry want the regulatory environment to change. Among the most far-reaching of the suggestions is a call for harmonization of the regulations covering the selection of donors and plasma in the United States and Europe.
Plasma from the US is used to treat patients in Europe, but with regulations covering the first step of the process differing in each region, members of the industry think the work entails unnecessarily duplicated efforts. Others said the requirement for European regulators to inspect plasma suppliers every two years, regardless of whether the US Food and Drug Administration (FDA) has also visited the site, is a poor use of resources. Mutual recognition of inspection reports could cut costs.
The International Plasma Fractionation Association (IPFA) also railed against the trend for ever-larger clinical trials of new or modified plasma products. IPFA said the trend is most pronounced in studies of coagulation factor products. As the shift makes it harder and more expensive to run clinical trials, IPFA views it as being detrimental to the interests of patients. – Nick Paul Taylor
Creativ Ceutical Report
What do Regulatory Pros Need to Know About Personalized Medicines and Companion Diagnostics in the EU?
The shift from “one-size-fits-all” medicinal products to more targeted and customized drugs is introducing new challenges for the people involved in the development and commercialization of such products.
One of those challenges: Knowing how to bring your personalized medicine product to market. Want to learn how? Attend this upcoming RAPS workshop and hear from experts and EMA regulators involved in the regulation of personalized medicine. Register by 11 May 2015 to attend this essential event. [Read More...]
Commission Passes Laws Covering Import and Traceability of Human Tissues
The European Commission has adopted two sets of rules covering the import and traceability of human tissues and cells, areas that could become increasingly important in the region if advanced therapy medicinal products (ATMPs) take off.
In the first document, the commission sets out the technical requirements of its plan to trace tissues and cells from donor to recipient and back again. The aim is to ensure regulators can quickly identify everyone who received material from a particular donor in the event of a safety alert. However, the ability for the system to track material once it is in the possession of an ATMP manufacturer is unclear. The law mandates traceability “at least until transferred to the ATMP manufacturer.”
The second piece of legislation, which covers the import of human tissues and cells from outside the European Union, is more definite in the requirements it places on ATMP manufacturers. Any organization that sources human cells and tissues from outside the EU must comply with requirements set out in the legislation, which include an obligation to report suspected adverse events to suppliers immediately. – Nick Paul Taylor
Traceability Law, Import Law, Commission Notice
EMA Posts Guidelines on Preventing and Reporting Medication Errors
The European Medicines Agency (EMA) has introduced three draft guideline documents designed to prevent medication errors. One of the documents is focused on high-strength insulin, while the other two are part of EMA’s implementation of the pharmacovigilance law that was passed in 2012.
Under the pharmacovigilance law, companies must report adverse events triggered by medication errors. EMA is trying to help the industry comply with this requirement by providing guidance on how to record, code, report and assess such adverse events. The guidelines ask marketing authorization holders (MAHs) to record, report and assess all medication errors that they hear about, regardless of whether an adverse event occurred.
EMA published the guidelines in conjunction with another document on how to prevent medication errors. The prevention guidelines detail the steps MAHs should take from early product development onward to curb the risk of medication errors. By considering the causes of such errors and how they relate to the product being developed, EMA thinks companies can build a picture of the risks and benefits of a medicine before it comes to market.
The third draft is focused on risk minimization strategies specifically tailored to high strength and fixed combination insulin products. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has raised concerns about these products in the past, prompting the regulator to create dedicated guidelines. MAHs are encouraged to use the guidelines — which cover the need to prevent mixups between long-acting and short-acting insulins — as a checklist. – Nick Paul Taylor
EU Directive Amended to Allow Lead, Mercury in Some Medical Devices
Two new directives have been added to the Official Journal of the European Union amending Annex IV to Directive 2011/65/EU, which restricts the use of certain hazardous substances in electronics. Commission Delegated Directive (EU) 2015/573 and 2015/574 amend Directive 2011/65/EU to allow exemptions for the use of lead and mercury in specific types of medical devices.
Directive (EU) 2015/573 specifically creates an exemption for using lead in polyvinyl chloride (PVC) sensors for in-vitro medical devices. The amendment states that lead should be used in PVC sensors as it is required as a stabilizer when processing PVC for sensor applications. While alternatives are being developed, they currently do not meet performance standards for these diagnostic devices. The exemption for lead use in this manner will apply until 31 December 2018.
Directive (EU) 2015/574 provides an exemption for the use of mercury in high-frequency intravascular ultrasound imaging systems. The directive states that replacing mercury in electric rotating connectors in these devices would either be infeasible or make the devices less effective. The exemption for mercury used in this application will apply until 30 June 2019. – Michael Mezher
Official Journal of the European Union
Industry Group Urges EU to Keep Pace With Pharmaceutical Legislation
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is encouraging European Regulators to keep their "foot on the gas," to address the many challenges that remain in the healthcare arena.
At a recent event celebrating the 50th anniversary of European pharmaceuticals legislation, Severing Schwan, CEO at Roche, and Andrzej Rys, director of the European Commission's Health and Food Safety Directorate agreed that more effort must be put into harmonizing regulatory and reimbursement frameworks in Europe.
Schwan also urged regulators not to be complacent in the future to keep the EU from being "out-performed" by the US in its regulatory performance. Schwan did note that the European Medicines Agency (EMA) has led some recent progressive initiatives, including the adaptive pathways pilot project. Schwan also argued that inefficiencies between regulators and health technology assessment (HTA) bodies are having a negative effect on patients.
At the same time, Rys celebrated efforts in Europe to promote innovative medicines and improve the regulatory environment for pediatric and orphan medicines. – Michael Mezher
Big Pharma-Funded COPD Draft Released for Consultation
EMA has released the results of an industry-funded initiative to develop a patient-reported outcome (PRO) instrument for chronic pulmonary disease (COPD) for comment.
Evidera developed the EXACT and E-RS tools — both of which are already used in COPD trials — with financial support from a consortium of leading drugmakers, including Merck, Novartis and Pfizer. EMA has now released details of the tools, how they have been assessed and the discussions triggered by the evaluations for comment. Interested parties have until May 25 to comment on the draft.
The publication of the document comes 15 months after FDA released draft guidance related to Evidera’s COPD tools. In the document, FDA stated EXACT is qualified for use in measuring the symptoms of acute bacterial exacerbation of chronic bronchitis in COPD patients. – Nick Paul Taylor
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has posted a follow up to Carestream Health’s January warning about its dental X-ray system. In the new post, MHRA asks users to contact their dealer so Carestream can inspect their devices and replace faulty parts. The earlier warning said there was no need for users to take any action. MHRA Notice
Members of the European Parliament have proposed revising the law covering the marketing of antibiotics to eliminate possible conflicts of interest between manufacturers and prescribers. The proposal is part of a set of measures intended to address antimicrobial resistance. The full house is due to vote on the report next month. Press Release
EMA has released an updated compilation of its guidelines on showing bioequivalence of specific products. The update adds an annex covering guidance for carglumic acid, imatinib, memantine, oseltamivir and posaconazole. EMA plans to bring the guidance into effect on 1 October. EMA Guidelines
MHRA has released details of five rulings on advertising complaints. The regulator upheld a complaint Johnson & Johnson made about a herbal medicine advert by Omega Pharma. Omega has agreed to change the advert to clarify its product is a herbal medicine. Merck also agreed to change an advert for Januvia in response to a complaint about the prominence of dosage restrictions. MHRA Rulings
A bumper batch of companies received CE Marks for their medical devices. Cepheid, Eyenuk, Hansen Medical, Medtronic, Mobidiag and Sophia Genetics all secured the status for devices including in vitro diagnostics, pacemakers and robotic catheters. Cepheid, Eyenuk, Hansen Medical, Medtronic, Mobidiag, Sophia Genetics
EMA has posted a reflection paper on the data requirements for assessing the similarity of intravenous iron-based nano-colloidal products. The regulator thinks quality characterization alone will prove insufficient to show similarity, prompting it to float the idea of using a “weight of evidence approach” that incorporates data from nonclinical and human studies, too. Reflection Paper
The United Kingdom’s National Institute of Health and Care Excellence (NICE) has decided to stop publishing guidelines until after the general election. NICE is concerned one of its rulings could become part of the political debate. PMLiVE
The UK Parliament is amending the Misuse of Drugs Regulations 2001 to increase restrictions on prescribing temazapam, raise ketamine to a Schedule 2 drug and allow some healthcare providers additional prescribing authority. Physiotherapists will also be allowed to prescribe some restricted drugs, including diazepam, dihydrocodeine, fentanyl, lorazepam, morphine, oxycodone and temazepam. Additionally, chiropodists and podiatrists will be able to write prescriptions for diazepam, dihydrocodeine, lorazepam and temazepam. The Pharmaceutical Journal
EMA has added clarification on specific changes to a product that would result in a drug or medical device receiving a new EU number when completing Type-IA, Type-IB, or Type-II variations.
EMA's small- and medium-sized enterprise (SME) office has released its quarterly newsletter detailing a number of recent and forthcoming regulatory guidelines and other information relevant to SMEs. SME Office
Medscape investigates the controversial practice of "pay-to-delay," in which companies whose patent for a product is about to expire attempt to delay competition by paying generic companies to hold off on releasing competing products. The practice is currently being challenged in the US by the Federal Trade Commission (FTC) and made headlines in 2013 when the European Commission fined Johnson & Johnson and Novartis €10.8 million and €5.49 million, respectively, for violating EU antitrust laws after their Dutch subsidiaries tried to delay the release of a generic copy of the drug Duragesic. Medsccape