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Posted 17 November 2017 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
A European drug trade group has warned there is too little time to move marketing authorizations before the Brexit date. The European Federation of Pharmaceutical Industries and Associations (EFPIA) wants regulators to show flexibility in the face of the anticipated time crunch facing firms with centrally approved products.
If, as anticipated, the UK is classed as a third country once the Brexit deadline passess in March 2019, operations based in the country will cease to be valid in the eyes of the European Medicines Agency (EMA). This means marketing authorization holders (MAHs) will need to move their approvals and supporting infrastructure to one of the remaining 27 European Union member states to avoid disruption.
EFPIA has questioned the practicality of making this transition by March 2019, though. In a slide to accompany results from a survey of its members, the trade group shows the ongoing, non-Brexit regulatory procedures the MAH for an illustrative, centrally approved product will need to handle between now and March 2019. The series of assorted variations and periodic safety update report submissions come back to back, with only brief lulls in regulatory activity in between.
That is a problem, given the time it will take to gain the regulatory clearances needed to transfer an MA. EFPIA said MAHs will need a clear window of 150 days, 60 days for the MA transfer and 90 days for the type II chemistry manufacturing and controls variation for the new product release and test site. No such window exists in the example presented by EFPIA.
The trade group thinks that will be the case for many of the products affected by Brexit. EFPIA calculates 17% of all centrally authorized drugs have UK legal entities that will need transferring. That amounts to 5,000 months of regulatory review EFPIA members need to squeeze in among their existing lifecycle management activities. Moving batch release to remaining EU states will take a further 4,000 months.
Faced with the time constraints, EFPIA wants regulators to take a “more flexible approach.” It is unclear how this will work in practice or if regulators will embrace the idea. Statements published by EMA to date have been clear about the need for companies to move tasks such as batch release from the UK. In theory, a less-abrupt transition could benefit all parties, but the lack of progress in the broader negotiations to date raises doubts about the likelihood of an agreement being reached.
EFPIA laid out its concerns in a slidedeck that highlighted multiple other problems that may arise as a result of Brexit. Almost half of EFPIA’s members expect trade delays if the UK crashes out of the EU without a deal and reverts to World Trade Organization rules. In that scenario, tariffs would go up between the UK and EU and, potentially more critically, the frictionless transfer of products across the English Channel would cease.
Survey Summary, Press Release, Reuters
MedTech Europe wants Brexit negotiators to factor in the predominance of UK notified bodies in CE marking activity when planning for life after March 2019. The trade group warned loss of UK capacity “could not be easily or quickly replaced” and could delay marketing authorizations.
The issue, as with many other Brexit-related regulatory matters, centers on what happens if the UK is classed as a third country with no special relationship to the EU as of 29 March 2019. This would void CE marking certificates issued by notified bodies based in the UK. To mitigate disruption, firms could move their certificates to one of the remaining 27 EU member states. However, given that UK notified bodies account for a lot of CE marketing activity, this could strain the system
MedTech Europe's preference is for the EU to recognize existing, valid CE marking certificates held by UK notified bodies until they expire. This would create a transition period. The trade group also wants UK notified bodies to remain in the European network and retain the power to assess devices for the rest of the EU. Switzerland provides a precedent for this model.
Fears about the impact of failing to smooth the transition are magnified by the incoming Medical Devices Regulation (MDR). Specifically, MedTech Europe is worried the removal of UK notified bodies from the system will exacerbate existing doubts about whether the EU has enough auditors for MDR.
The incoming regulations come up repeatedly in MedTech Europe’s position paper. MedTech Europe wants the UK to fully align with the recently adopted legislation, including guidance documents and related pieces of secondary legislation, to avoid a situation in which companies must work with two diverging systems.
A European Parliament committee has called for public health to be given special treatment in planned regulation of professions. Members of the Committee on the Environment, Public Health and Food Safety (ENVI) fear the proposals could be harmful to healthcare.
The European Commission wants to bring the changes into force to make the regulations member states apply to professions more transparent and comparable. That could move the EU closer to being a single employment market. However, ENVI thinks in trying to fix one problem, the Commission will create a new set of difficulties for people working in healthcare.
“With regard to healthcare professionals and the need to protect public health, [rapporteur Françoise Grossetête] considers that the Commission’s proposals would be too complex to implement and would involve too much red tape. It would be wrong to adopt such restrictive horizontal legislation to resolve specific problems,” ENVI wrote in its opinion.
ENVI asked the Commission to exclude healthcare jobs from the proposals earlier this year. Now, it wants the Commission to write an override mechanism into the legislation that stops the rules from harming public health. These safeguards include a line that the requirements “should not prevent Member States from taking immediate measures in the field of health care which they consider necessary.”
EMA has created a question and answer document to help assessors of periodic safety update reports. The Q&A covers points that have proven challenging in the PSUR single assessment (PSUSA) procedure to date.
In the document, EMA runs through the basics of the procedure, starting with its aims and the data to be reviewed, before delving into more specific points.
Subjects covered by the document include the use of PSUSAs as tools for harmonizing the summary of product characteristics, the role of tables of cumulative safety data in signal detection and how to deal with a range of types of discrepancy.
EMA selected the points to cover in the Q&A based on the experience it has accrued since it began using the PSUSA procedure for nationally authorized products at the start of 2015. Some of the answers provided by EMA are also relevant to PSURs of centrally authorized products.
Tags: European Regulatory Roundup, EU Regulatory Roundup
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