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 raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 13 October 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The politician in charge of negotiating the United Kingdom's exit from the European Union has said he will seek to get "standardized" approval processes. David Davis made the comment in response to concerns raised by AstraZeneca CEO Pascal Soriot about the effect of Brexit on how long it takes the UK to access to new drugs and how much they cost.
Talking to The Sunday Times, Soriot said drugmakers prioritize getting their products approved in the United States, Europe, China and Japan. As a member of the European Union, the UK is among the first countries to gain access to new medicines, if it agrees to pay for them. However, if the UK sets up its own drug approval system upon leaving the EU, Soriot thinks it will fall down the pecking order. The CEO envisions the UK joining Australia and Canada in the second wave of nations to gain access to new drugs. Also, if the new system increases AstraZeneca's costs, it will raise its prices in the UK.
Daniel Zeichner, a politician in the opposition who represents the biopharma hotspot of Cambridge, put Soriot's comments to Davis during a debate on leaving the EU. Specifically, Zeichner asked Davis if Soriot was right to say the absence of a common approval process with the EU would increase the cost of drugs to the National Health Service. While sidestepping the question, Davis revealed a clue about how he foresees the drug approval process working if the UK leaves the EU as expected in 2019.
"I am not in a position to do those sums for the honorable gentleman, but I will tell him that that is one of the things that we will seek to get standardized," Davis said. In keeping with the government's resistance to saying more about its Brexit strategy than is absolutely necessary, Davis gave no further details, opting instead for a vague statement about the importance of life sciences. "There will be a number of areas such as life sciences where we have a big interest. We are, after all, the largest life science centre in Europe, so that will be front and center of our negotiations," he said.
Zeichner's question was one of two about the future of the pharmaceutical sector post-Brexit that politicians put to Davis during the debate. The other came from a politician representing part of the city of Liverpool in which Eli Lilly has a manufacturing plant. In response to a request for reassurance about the future of the drug sector, Davis said: "I do not think the pharmaceutical industry is running away from this country — just the reverse." Davis cited a post-referendum investment commitment from GlaxoSmithKline to support his case, before giving his take on why drugmakers are in the UK.
"The pharmaceutical industry is predominantly in the UK for reasons that relate to intellectual property among other things," he said.
This week also saw a small group of UK politicians meet to discuss the future of the European Medicines Agency (EMA). However, as Davis and other politicians involved in making Brexit happen were in a separate, broader discussion of the split at the same time, little, if anything, conclusive was said.
"I have no idea how [EMA's location] will end up," David Mowat, a politician involved with the Department of Health, said. "For me to say it is an absolute line in the sand that the EMA must stay in the UK would be a nonsense."
Debate Transcript, The Sunday Times,More
EMA is planning to collate the good manufacturing practices (GMP) that relate to marketing authorization holders (MAHs) to clarify who is responsible for what tasks. EMA thinks such a document is needed to centralize disparate information regarding the roles of MAHs and contract manufacturers.
Members of the GMP/GDP Inspectors Working Group made their case for a central document, which would take the form of a reflection paper, in a draft concept paper. In the concept paper, the working group sets out the perceived shortcomings of the current system and how the creation of a reflection paper would make life easier for MAHs, manufacturers, GMP inspectors and other groups involved in ensuring the quality of pharmaceuticals. The idea is not to create additional responsibilities. Rather, EMA wants to clarify the intent of its existing regulations.
"The way in which MAHs are expected to interact with the manufacturing sites registered in a marketing authorization is not sufficiently clear," EMA wrote. "Some MAHs are not clear on their responsibilities. When MAHs and manufacturers are different companies and/or separate legal entities, it becomes increasingly important to clearly define the role of the MAH in facilitating GMP compliance at outsourced manufacturing and control organizations. Furthermore, certain important activities of MAHs with respect to ensuring GMP and MA compliance are not well addressed."
The concept paper highlights approximately 10 specific sections of regulatory documents that relate to the GMP responsibilities of MAHs. Some of these are sources of confusion. For example, chapter one of the EC Guide to GMP tasks MAHs with evaluating the results of product quality reviews and assessing whether corrective or preventative actions are needed. This is true regardless of whether the MAH or a contract manufacturer produced the drug. Yet, in EMA's experience, MAHs are failing to evaluate the quality reviews.
EMA has given industry until the end of November to comment on its concept paper. Once the comments are in, a drafting group will start work on a reflection paper. The aim is to agree upon a reflection paper by June 2017.
Concept Paper
EMA has released three pre-submission checklists to help MAHs with various renewals. The texts detail the information MAHs need to include when filing annual reassessments, five-year renewals and submissions related to conditional marketing authorizations.
Each document includes a table detailing the information MAHs need to provide, a checkbox to tick once they have met the requirement and comments to expand on and clarify what EMA wants. The checklist for five-year renewal applications, for example, instructs MAHs to include a cover letter, details of the qualified person, a recent certificate of GMP compliance and other information in their submissions.
MAHs going through the other renewal processes must provide a slightly different set of information, both from each other and their peers going through the five-year pathway. MAHs with conditional approvals and those granted under exceptional circumstances may need to provide clinical study reports to meet specific obligations detailed at the time of the approval. These reports are needed to meet post-approval obligations to demonstrate the safety and efficacy of the drug.
The checklists do not place additional requirements upon MAHs going through the various renewal processes. Rather, the checklists are designed to help MAHs ensure they include all the necessary information in their filings.
Annual Checklist, Five-Year Checklist, Conditional Checklist
The Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the approval of a drug to protect honeybees from parasites. CVMP made the decision on the drug from BeeVital at its October meeting. Press Release, More
Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Regulatory Focus newsletters
All the biggest regulatory news and happenings.