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 firstname.lastname@example.org 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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 23 April 2015 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has called on the European Commission to place limits on transatlantic regulatory cooperation. ENVI made the request as part of the debate over the scope of the Transatlantic Trade and Investment Partnership (TTIP).
Rapporteur Bart Staes laid out ENVI’s concerns in 22 bullet points, the fifth of which requested that the regulatory cooperation allowed under TTIP is constrained to “specified sectorial areas where the [United States] and the [European Union] have similar levels of protection.” ENVI would also allow cooperation in areas in which there are reasonable grounds to think existing divergences in regulations can be closed by raising standards in one region.
The stipulations reflect concerns that TTIP will force Europe to adopt less stringent regulations to harmonize with the US. Point four raised by ENVI also deals explicitly with these fears. Staes asked the commission to take steps to eliminate the risk TTIP will lower standards of current, planned and as-yet undrafted legislation. The rapporteur is worried TTIP could affect Europe’s approach to topics such as endocrine-disrupting chemicals when it gets around to drafting a policy.
ENVI has released at least three sets of comments about TTIP in 2015 as it seeks to close off perceived flaws in the text ahead of planned votes on TTIP at the end of May and early June. There are some signs that the push is having an effect. A chapter on cosmetics that previously mandated “mutual recognition” of banned and approved ingredients has been toned down. However, a leaked chapter on regulatory cooperation has stoked fears of a corporate power grab.
ENVI Opinion, EurActiv, CommonDreams
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...]
The European Medicines Agency (EMA) has pushed back the date by which companies must apply to take part in its generic medicine information-sharing pilot program. EMA originally set the deadline for March 31.
In the three months since EMA began accepting applications, it has decided companies need more time to get their paperwork together. The latest release contains no date on which EMA will stop accepting applications. Instead, EMA is simply encouraging firms to send it expressions of interest in the pilot program at least eight weeks before they file paperwork for the centralized procedure.
The original plan was to put 10 applications for generic drugs through the pilot procedures. EMA was joined in the program by its peers in Australia, Canada, Chinese Taipei and Switzerland, each of which has agreed to undertake “separate but synchronized” assessments of generic drugs and share their final reports.
A European Commission proposal to separate legislation covering human and veterinary medicine has moved a step closer to coming into force after the ENVI rapporteur broadly backed the plan. The rapporteur is supportive of the decoupling, but has some reservations about fees.
Rapporteur Claudiu Ciprian Tănăsescu has taken issue with the structure and level of fees EMA will receive. In particular, Tănăsescu wants to ensure the European Parliament has as active a role in the setting of fees in this situation as it does in pharmacovigilance. “Your rapporteur proposes a full co-decision process in this regard,” Tănăsescu wrote.
While Tănăsescu’s feedback suggests some fine tuning is needed if the plan is to come to fruition, the rapporteur’s broad support bodes well for the chances of the big idea of the proposal winning widespread support. Other committees have also expressed a belief that the differences between human and veterinary medicine are significant enough to make a split a sensible move.
EMA has released more advice to help companies prepare for the collection of pharmacovigilance fees. The regulator will start to collect annual fees on July 1, by when it is recommends market authorization holders (MAHs) have liased with their qualified persons for pharmacovigilance.
MAHs and their qualified persons are advised to check the advice notes provided by EMA this week. In the advice notes, EMA provides a listing of the chargeable units it will use to calculate pharmacovigilance fees. MAHs have until June 30 to identify any errors and make the necessary updates and amendments to the Article 57 database.
EMA released the advice notes in conjunction with a Q&A document and video tutorials on pharmacovigilance fees. The Q&A covers uncertainties MAHs may have about the advice notes, such as who will receive the list, the definition of “chargeable unit” and how fees are calculated for different strengths of the same product.
EMA Release, Pharmacovigilance Q&A
EMA has provided applicants and existing MAHs with a checklist to help them prepare for oral explanations. The list details the process that takes place before such a meeting with the regulator and what companies can expect on the day.
For companies unfamiliar with the process, the guidance gives a detailed explanation of what will happen and when, starting with EMA setting a time for the meeting at least seven working days in advance. The document then lays out what is required from companies and advises them not to arrange travel for too close to the end of their scheduled appointment in case it is delayed.
EMA also outlines what will happen on the day of the oral explanation. Companies must arrive at least 30 minutes before their appointment and keep their presentations to no more than 20 minutes in length.
Researchers have found two-thirds of newborns in Europe who are given common medicines are exposed to potentially dangerous excipients. The paper, which was published in BMJ, looked at the prescriptions of 89 neonatal intensive care units in 21 countries. “Quite a few excipients could be avoided by using different versions of the same medicine,” an author said. Reuters
EMA has released a concept paper on the development of guidance on the quality and equivalence of topical products. Such products present particular equivalence challenges, as small changes in the formulation or manufacturing process can have a notable effect on safety and efficacy. EMA is planning guidelines to address the topic. Concept Paper
Belgium and the Netherlands have agreed to jointly negotiate deals for orphan drugs in an attempt to increase their bargaining power. The countries think combining their patient populations will help them to drive down prices in negotiations with sellers of rare disease drugs. Belgium has been looking for a solution to the pricing issue since its spat with Alexion. Reuters
EMA has published a draft revision to guidelines covering the use of the common technical document (CTD) in submissions for traditional herbal medicines. The revision marks the second time EMA has reworked the document since it first came into force in 2008. The latest changes cover CTD summaries, as well as clinical and non-clinical study reports. Draft Guidelines
The Council of Europe has adopted a resolution to improve the use of immunoglobulin therapies. Officials drafted the resolution in an attempt to harmonize the availability and use of the therapies across Europe. Specific recommendations include an expansion of the Health Technology Assessment of immunoglobulin therapies. EDQM Notice
Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup