Regulatory Focus™ > News Articles > 2021 > 7 > Euro Roundup: France posts guidance on developing drug shortage management plans

Posted 29 July 2021 | By Nick Paul Taylor 

Euro Roundup: France posts guidance on developing drug shortage management plans

2911 The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage management plans for drugs of major therapeutic interest.
In March, France published a decree to establish an obligation for pharmaceutical companies to have buffer stocks of medicines to mitigate the risk of shortages. The amount of stock companies need to carry depends on the importance of the drug. France will require manufacturers of drugs of major therapeutic interest to have enough stock to supply the market for two months. ANSM can increase the stockpile to four months if a company has repeated supply problems.
The publication of the decree, which is set to take effect on 1 September, led ANSM to seek feedback on the shortage management plans that must be drawn up by manufacturers of medicines of major therapeutic interest. The plans are intended to enable the identification of risks to supply and cut the time it takes to enact mitigating measures in the event of disruption.
Having received 37 responses to its June consultation, ANSM has provided an update on its vision for the shortage management plans. ANSM said each plan must contain general information about the medicinal product, such as its indications, and an assessment of the risks that could lead to supply shortages.
The regulator also wants to know what measures the manufacturer has taken to counter the risks and what would happen in the event of a shortage. Risk-management measures suggested by ANSM include buffer stocks and alternative manufacturing sites. ANSM listed alternative drugs and imports as ways to mitigate shortages.
ANSM has released a five-page guidance document to help manufacturers create their plans. The agency expects manufacturers to submit their current plans in December each year.
ANSM Notice (French)
EMA updates Q&A on clinical pharmacology and pharmacokinetics
The European Medicines Agency (EMA) has updated a question-and-answer document on clinical pharmacology and pharmacokinetics. EMA has added a new question about fixed combinations with highly soluble active substances.
Last summer, EMA added a question about interpreting conditions regarding fulfilling proportionality in composition of fixed combinations in applications with multiple strengths. The new query builds on that question by discussing the deviations from proportionality in composition that are allowed for fixed combinations with highly soluble active substances in applications with multiple strengths.
EMA’s answer explains that when working with fixed compositions that consist of multiple strengths, small differences in proportionality of compositions may trigger regulatory requests for additional in vivo bioequivalence studies.
However, the situation is different if all the active substances are highly soluble. In that scenario, the risk of non-bioequivalent additional strength formulations is “negligible,” EMA said, provided certain conditions are fulfilled. The conditions include the demonstration of bioequivalence at the most sensitive strength and the use of the same manufacturing process for the additional strength.
If the conditions are met, EMA said a waiver for additional strengths is acceptable. The waiver applies even if the additional strengths deviate from proportionality in composition. EMA has created several examples to show how the rules apply to active substances with various properties. 
MDCG shares instructions for generating unique single identification numbers
The Medical Device Coordination Group (MDCG) has released guidance on how to generate the unique single identification numbers (CIV-IDs) needed for clinical investigations under the new regulatory framework.
A CIV-ID serves as a European tracking number that identifies a specific clinical investigation under the Medical Device Regulation (MDR). MDCG, which helps the European Commission harmonize the implementation of MDR, has created instructions that walk users through the process of generating a CIV-ID and describe when the action should be taken.
“As there is no possibility for sponsors to generate the Single Identification Number (SIN) foreseen in the MDR before EUDAMED is fully functional, member states may encourage sponsors to obtain a CIV-ID from a Competent Authority before the first submission of application/notification,” the MDCG guidance states.
Taking that approach allows sponsors to “use the CIV-ID throughout their clinical investigation documentation wherever the SIN would have been used if EUDAMED was available.” Alternatively, the competent authority may generate a CIV-ID upon receipt of a first submission. If the competent authority generates the CIV-ID, it should share the number with the sponsor so it can be used in later submissions to other member states. 
MDCG Document
Commission starts antitrust investigation into Illumina’s takeover of Grail
The European Commission has opened the next phase of its antitrust review of Illumina’s planned takeover of liquid biopsy company Grail. Illumina defended the deal, arguing it is pro-competitive and pointing to “far-reaching structural and behavioral remedies” it has proposed to address concerns.
As Grail is yet to generate significant revenues, the proposed $8 billion takeover does not meet the criteria for a traditional antitrust investigation in the European Union. Yet, with the Commission keen to broaden its antitrust activities in light of deals such as Facebook’s acquisition of WhatsApp, the Illumina-Grail merger has become the focal point of an effort to deploy an old but largely unused antitrust mechanism.
The Commission opened an in-depth investigation into the Illumina-Grail deal after its preliminary assessment identified concerns with the takeover. As the Commission sees it, as Illumina provides the sequencing equipment used by Grail and its rivals the takeover could lead it to “engage in vertical input foreclosure strategies” that affect “crucial inputs for the development and commercialization of NGS-based cancer detection tests.”
It will take up to 90 days for the Commission to reach a decision on the takeover. The timeline suggests Illumina will learn if it has European support for the deal weeks before it needs to close the takeover.
Commission Notice, Illumina Statement
EMA updates veterinary medicines guidelines to align with new regulations
EMA has updated multiple veterinary medicinal product guidelines to align the definitions and terminology with the new regulatory framework covering the sector.
The update to the guideline on statistical principles for clinical trials for veterinary medicinal products is indicative of the changes EMA has made to the documents. EMA said the revision consists of administrative changes to align the guideline with the Veterinary Medicines Regulation that is set to take effect early next year.
Officials also used the revision to update “references to the legislation applicable and other scientific guidelines.” As the scientific content of the guideline is unchanged, EMA made the revisions without publishing a concept paper or holding a public consultation.
EMA Guideline
Other News:
EMA has adopted a reflection paper on promoting the authorization of alternatives to antimicrobial veterinary medicinal products in the EU. The agency finalized the paper almost two years after holding a consultation that attracted comments from 11 organizations. EMA made major changes to the paper after going over the feedback. The next step is to discuss recommendations on regulation of alternatives to microbials with other European authorities. Reflection Paper
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public and healthcare professionals about inaccurate infrared thermometers. MHRA wants people to take care when buying the products in light of the growth in the number of unreliable infrared thermometers available in the UK. MHRA Notice


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you