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.
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 | 03 November 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The Medical Products Agency (MPA) of Sweden has published a report ahead of an anticipated uptick in the use of the adaptive approval pathway in Alzheimer's disease and other indications. MPA wants to set up working groups to solve issues it identified with the application of the model to Alzheimer's, while also taking steps to involve patients more in the process.
MPA conducted its review into the implications of the staggered-approval pathway, particularly as it applies to Alzheimer's, in parallel to the European Medicines Agency's (EMA) pilot project. With EMA committing to continuing to offer the adaptive approval pathway beyond the conclusion of the pilot project, MPA has published what it has learned from its involvement in the EMA's program and its own review of the process. The report lists the tasks MPA now plans to undertake in preparation for more drugs following the pathway.
Priorities include the creation of one or more working groups. MPA thinks these groups are needed to work through the challenges identified at a workshop it organized on the use of the pathway for Alzheimer's drugs. The workshop identified Sweden's health data records, which include a dementia registry, as a valuable resource, but found room for improvement. The registry currently lacks a mild cognitive impairment population. Given the current focus in Alzheimer's R&D on patients in the early stages of the disease, this is an important population for the adaptive pathway.
MPA wants working groups to prepare the health data sector for the introduction of an Alzheimer's drug while also addressing other potential problems. One task is to ensure the healthcare sector is prepared for an Alzheimer's drug. Potential bottlenecks include the availability of trained geriatricians and the capacity of MRI scanners. MPA also expects the working groups to look at the pricing model. The groups may work on these tasks as part of a national strategy on dementia set up by the Swedish government.
Officials at MPA also want to bring patients into the process. MPA thinks patient feedback will help with study design, selection of clinical outcome measures and other areas. A group is due to meet to discuss these topics early next year. A separate meeting with dementia patient associations is also planned.
Press Release,MPA Report (both Swedish)
The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has gathered 617 suggested amendments to its proposal to improve access to medicines in the region. Politicians' breadth of responses to the initial draft demonstrate the diverse range of opinions within the European Union about how best to manage drug prices and availability.
ENVI's original draft contained recommendations with the potential to unsettle drug manufacturers, including proposals to tax their profits to bankroll an EU public platform for R&D. Some of the proposed changes to the draft text go further still. A small group of politicians are pushing for the creation of a European Public Pharmaceutical Company. The company would focus on indications the politicians perceive as being overlooked by private business because of doubts about the return on investment they offer.
Other proposed changes seek to weaken potentially contentious recommendations. The proposal to tax drug company profits for an EU R&D fund was attacked by multiple politicians, whose suggestions ranged from deleting the whole section to neutering it through substantial rewrites. One proposal, backed by seven politicians, removes the reference to taking a share of industry profits and instead focuses on the value of having patient groups inform research priorities. Rewrites and deletions that similarly soften the impact of other recommendations occur throughout the document.
The hundreds of proposed changes do little to clarify the likely final form of the recommendations, but do show the extent of the disagreement on how best to approach the topic of access to drugs. Members of ENVI will discuss and vote upon the amendments at a meeting, after which those with the support of the committee will be incorporated into the final motion for a European Parliament resolution.
Part I, Part II
The Greek National Organization for Medicines (EOF) is working on a database of all medical devices made or sold in the country. EOF disclosed the plan in a document to discuss the use of conformity assessments and reporting of medical device quality failings.
Regulatory officials included scant details of the database in the text, but the information available suggests the idea is to encourage the registration of medical device companies and their products. The database will house details of all medical devices manufactured or marketed in Greece, and, in doing so, could help EOF build a picture of the market it regulates.
EOF included news of the planned database alongside other information relevant to manufacturers of medical devices and in-vitro diagnostics. The document classifies devices, outlines conformity assessment procedures and explains the use of CE marks, the EU standard that covers products in Greece and other countries in the region.
Another section covers the white card materiovigilance scheme. The scheme facilitates the simultaneous reporting to EOF and the manufacturer of faults with a medical device, its labeling or instructions that could lead to the death or serious harm of a patient.
The Finnish Medicines Agency (FIMEA) has translated its Meds75+ database into English. FIMEA maintains the database to provide information on the suitability of medicines for use in patients aged 75 years and older.
Each medicine in the database is put into one of four categories that indicate its suitability for use in elderly patients. A drug assigned an "A" rating is suitable for use in the elderly without any changes to the dose or frequency of administration. Category A drugs have comparable safety profiles in elderly and younger populations.
The other categories cover drugs for which there is a lack of data on use in seniors—group B—and those that are known to have different effects on elderly patients than younger people. For drugs in category C, it may still be safe to use the drug at a reduced dose or on a more infrequent schedule. Category D drugs are only to be used in exceptional or one-off situations.
FIMEA has categorized almost 500 medicines or combinations of therapies to cut the risk of a doctor inadvertently prescribing a product that is harmful to their patient. The regulator prepared and maintains the database with the support of pharmacologists, pharmacists and specialists in senior medicine.
The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted lists of outstanding issues for marketing authorization holders involved in four of its ongoing investigations. PRAC put together the lists to further the gathering of information on direct-acting hepatitis C drugs such as Gilead Sciences' Sovaldi and the SGLT2 inhibitor class of diabetes medicines. Meeting Highlights
The Committee for Medicinal Products for Human Use (CHMP) has adopted a guideline on clinical trials of drugs to prevent or slow the progress of chronic renal insufficiency. CHMP adopted the text after it was finalized in response to a consultation that closed last year. The final guideline will come into force on April 1. Final Guideline
Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup