Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ireland Creates Innovation Office to Provide Regulatory Advice
The Health Products Regulatory Authority (HPRA) of Ireland has created an Innovation Office to give advice to developers of novel health products and technologies. HPRA sees the office facilitating the timely development of innovative interventions by providing regulatory input early in the process.
Staff at the new office will work to ensure academics, drug developers, medical device companies and others understand how national and European Union regulations affect their plans. The goal is to provide developers of novel products — or approaches to manufacturing and testing of products — with a first port of call for regulatory advice. HPRA hopes that by engaging with developers early in the process, the office can save them from costly and time-consuming delays arising from a failure to understand and comply with regulations.
“As a regulator, we firmly believe that the application of our scientific and regulatory expertise can facilitate such innovation. This will ultimately lead to new products coming to market quicker as we build knowledge and awareness of both the processes involved and the supporting data that would be required to gain regulatory approval,” Lorraine Nolan, chief executive of HPRA, said.
The office is part of a broader attempt by HPRA to support innovation. HPRA is setting up an online query service dedicated to the areas covered by the office. The service is intended to give people a way to confidentially put questions to HPRA regulatory experts. HPRA has also created a section on its website dedicated to the innovation office and published a leaflet to promote its activities. The agency plans to follow up these online activities with an innovation day next year. HPRA wants to use the day to detail the support it can provide.
HPRA’s creation of the innovation office is in keeping with moves across Europe to ensure innovators have access to regulatory input early in development. The European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) are among the organizations to take steps to help companies. By joining them, HPRA intends to support innovation in Ireland.
EMA Advises Companies to Nominate two OMCLs to Prevent Shortages
EMA has updated its advice to manufacturers of products subject to batch release by an Official Medicines Control Laboratory (OMCL). The regulator is now recommending manufacturers “seriously consider” nominating two OMCLs to secure the supply chain and cut the risk of shortages.
OMCLs help regulators and national inspection services verify the quality of certain types of products by providing testing services. Manufacturers of live vaccines, immunological medicinal products and therapeutics derived from blood or plasma are among the organizations that can be subject to OMCL batch release. In 2010, EMA advised such organizations to start collaborating with an OMCL at least one year before filing a marketing authorization. That timeline was intended to ensure the company had enough time to share information with the OMCL and develop a suitable testing methodology.
EMA has now returned to and revised the advice it offered in 2010. All of the original guidance has been retained. The difference is EMA has added advice intended to secure the supply chain and stop shortages from arising. EMA thinks manufacturers can achieve these goals by liaising with a second OMCL on the development of testing methodology in the year before filing for approval. The agency also sees value in nominating a second OMCL for batch release once the product is approved and on the market.
The new advice is one of two changes to a document that answers questions about the centralized procedure. EMA has also changed the address companies should send notifications to when alerting it of their intention to submit multiple applications for a medicinal product. The regulator has also added an email address companies can use instead of sending hard copies. EMA’s advice from 2014 lacked details on how to communicate electronically.
CHMP Starts Review of Safety and Efficacy of Paracetamol-Ibuprofen FDC
The Committee for Medicinal Products for Human Use (CHMP) has begun a review of the safety and efficacy of a fixed-dose combination (FDC) of the painkillers ibuprofen and paracetamol. CHMP is looking at a formulation that delivers 500mg of paracetamol and 150mg of ibuprofen.
Members of the committee started a referral procedure for the combination at the last meeting. The action stemmed from disagreements about the safety and efficacy of the FDC, although CHMP gave no details of the nature of the concerns. EMA uses referral procedures to address concerns about the benefit-risk balance of medicines. Member states and the European Commission can call for EMA to trigger referral procedures when they are concerned about the safety of a product.
Auckland, New Zealand-based AFT Pharmaceuticals submitted a patent filing for an FDC of ibuprofen and paracetamol more than a decade ago. The product, Maxigesic, is now available in more than 100 countries, including Belgium and Luxembourg. AFT added the two European countries to its list of markets after forming a licensing agreement in September. Vale Pharmaceuticals is also cleared to sell a paracetamol-ibuprofen FDC by the UK’s MHRA.
AFT has run clinical trials of its formulation without unearthing safety or efficacy concerns. Taking separate tablets of ibuprofen and paracetamol at the same time is also seen as being safe. In its report on the practice, the UK’s National Health Service wrote, “There are no known harmful interactions between paracetamol and ibuprofen in people over 16.”
EMA Schedules Session to Educate Patients About Regulatory Activities
EMA has scheduled a training session for patients and consumers who want to learn more about its activities. The day-long gathering is part of EMA’s ongoing attempts to ensure patients are equipped to contribute to regulatory decisions that affect their lives.
At the meeting, EMA plans to give attendees a grounding in how medicines are evaluated in the EU before taking a closer look at the points in the process at which patients can contribute. EMA has picked out the choice of trial endpoints and feasibility of study designs as topics patients can contribute to during the development of new medicines.
The meeting will also cover opportunities to contribute once a drug has completed development. EMA plans to discuss the role of patients in assessing the risk-benefit profile of drugs and the unmet medical needs of populations. A Pharmacovigilance Risk Assessment Committee-focused session will take a closer look at how patients can influence what constitutes “acceptable” risk in an indication.
EMA held similar events in 2014 and 2015. The series grew out of the publication in 2009 of a reflection paper on further involving patients in EMA activities. That led to the creation of a training strategy designed to ensure patients have the knowledge needed to contribute effectively to regulatory activities.
Gilead Sciences has discontinued pediatric development of simtuzumab. The company sent a letter to EMA inform the regulator of its action after a series of failures in the clinic prompted it to end development of the LOXL2 blocker. EMA published an agreement on the pediatric investigation plan for simtuzumab late last year. Gilead LetterEMA
has scheduled a workshop to discuss the use of modeling and simulation in drug development. Press Release