Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 23 July 2015 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
A periodic review commissioned by the United Kingdom government has concluded the Medicines and Healthcare Products Regulatory Agency (MHRA) is doing a good job. Yet while the overall message is positive for MHRA, it still received a list of 21 recommendations the review team wants it to implement.
MHRA was assessed as part of the UK’s triennial review scheme. Importantly, the review found the regulator “performed well in the delivery of necessary functions” and should continue to operate in its current form. The outcome means there will be no radical overhaul of the UK regulator, which has instead been tasked with adopting tweaks intended to improve its finances and the effectiveness of its operations.
A handful of the proposals relate to the financial health of MHRA, which, like all state institutions in the UK, is being asked to save money. The recommendations include a review of how MHRA brings in money, for example by assessing whether the earnings potential of the Clinical Practice Research Datalink (CPRD) is being maximized. MHRA is working toward a previously agreed goal of aligning its income and expenditure by the next financial year.
The operational recommendations range from specific aspects of a plan to update MHRA’s IT system to broader adjustments to the regulator’s interactions with its international peers. For example, the review has tasked MHRA with working with authorities in other countries to establish a common method for the application of fees for the regulation medical devices.
The European Medicines Agency (EMA) and Swissmedic have entered into a data-sharing agreement. Under the terms of the arrangement, EMA and Swissmedic will share confidential information on the quality, safety and efficacy of medicines that are approved or being reviewed.
The deal is intended to cut down on the duplication of tasks between regulators in Switzerland and the rest of Europe, shorten the time it takes for new drugs to reach patients and increase the availability of safety reports. In a letter to pitch the new terms to Swissmedic, EMA Deputy Executive Director Andreas Pott highlighted four specific types of information the partners may share, while acknowledging that they could increase the scope of the deal beyond these fields.
The four areas picked out by Pott are guidance documents, pharmacovigilance data, information in applications and good clinical practice (GCP) inspection reports. Swissmedic accepted the terms of the agreement earlier this month, at which time the five-year data-sharing collaboration started. DG Sante and the Swiss Federal Department of Home Affairs are also covered by the agreement, which includes various stipulations to protect the rights of companies and other third parties.
EMA Notice, Swissmedic Notice, EMA Letter, Swissmedic Letter
An independent task force set up by NHS England has called for the fast finalization and adoption of the European Union Clinical Trial Regulations. The recommendation is a central component of the task force’s vision for how the UK can cut the time it takes to set up oncology clinical trials.
The 19-person task force, which was headed up by Cancer Research UK’s Harpal Kumar, found that the regulatory and governance framework in the UK is one of the main barriers to running clinical trials. To improve the situation, the task force recommended the fast tracking of the EU Clinical Trial Regulations, a set of laws it thinks will shorten the time it takes to set up studies, while also improving the viability of research into rare cancers and those affecting young people.
In a separate recommendation, the task force calls on the Department of Health to fix governance problems that are making it hard for legitimate, compliant research organizations to access patient data. The recommendation extends to the creation of a legal framework to ensure data flows easily between MHRA, Public Health England, the National Institute for Health Research and the Health & Social Care Information Centre.
Task Force Report
EMA has released a bumper batch of regulatory documents. The regulator posted at least 10 documents this week, including guidance on pharmacovigilance fees, a concept paper on finished dosage forms and a reflection paper on cocrystals of active substances.
More than half of the documents are the result of work by the Committee for Medicinal Products for Veterinary Use (CVMP). CVMP was a driving force behind draft guidelines on the production and control of immunological veterinary medicinal products, a draft concept paper on manufacturing finished dosage forms, a draft reflection paper on ensuring seeds used in making immunological therapies are free from extraneous agents and a document on the chemistry of active substances.
CVMP was also involved with the creation of the cocrystals reflection paper, a concept paper on the development of penicillin resistance in animals and recommendations on reduction, refinement and replacement methods for animal testing. The final three documents are the aforementioned recommendations on calculating chargeable units for pharmacovigilance fees, a draft qualification opinion on using total kidney volume as a biomarker and final guidelines on sodium fluoride (18F).
Pharmacovigilance, Finished Dosage Forms, Cocrystals, Immunological Control, Immunological Seeds, Active Substances, Penicillin, 3Rs, Total Kidney Volume, Sodium Fluoride
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reappointed its chair and vice chair for a second three-year term. Dr. June Raine and Dr. Álmath Spooner took the roles of chair and vice chair, respectively, in 2012. Now, having had their mandates extended, both are set to continue in their positions until September 2018. Press Release
Amgen is set to beat Sanofi in the race to win approval of a PCSK9 cholesterol drug in Europe. The companies have been pushing hard to bring their blockbuster candidates to market on both sides of the Atlantic. Sanofi used an expensive priority review voucher to gain an edge in the United States but Amgen is now expected to be the first to receive a recommendation in Europe. FierceBiotech
The British Pharmacopoeia Commission (BPC) has begun the process of recruiting eight new members. The Secretary of State for Health plans to name six professionals and two lay people who will serve four-year terms at BPC. Applicants can express an interest in taking up the posts between now and 1 September. Press Release
EUnetHTA has released a position paper on the formulation of research recommendations. The document is intended to help health technology assessment (HTA) reviewers frame the requests for additional evidence generation, in particular by providing a structured approach to the identification of gaps in the existing research. EUnetHTA Statement, Position Paper
Sonia Ruiz Moran has taken over as president of the European Medicines Verification Organisation (EMVO), the group set up four months ago to work on protecting the supply chain from falsified medicines. Moran replaces John Chave, the former secretary general of Pharmaceutical Group of the European Union. EFPIA Statement
The European Parliament committee on the Environment, Public Health and Food Safety (ENVI) has gone fully paperless. The switch, which came in on 1 July, means that when ENVI next meets on 3 September, no paper documents will be available for attendees. Instead, attendees will access the documents through the “Meeting Documents” tab on the ENVI website. ENVI Notice
Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup