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Euro Roundup: EDQM clarifies implications of new sartan monographs

Posted 04 March 2021 | By Nick Paul Taylor 

Euro Roundup: EDQM clarifies implications of new sartan monographs

The European Directorate for the Quality of Medicines (EDQM) has explained the implications of new sartan monographs for the holders of a currently valid Certification of Suitability (CEP).
 
Last month, EDQM said monographs for five sartan medicines, which were rapidly revised considering the risk of contamination with N-nitrosamines, will take effect 1 April. However, EDQM’s February update lacked details of how the revised monographs will affect suppliers of valsartan, losartan potassium, irbesartan, candesartan cilexetil and olmesartan medoxomil.
 
EDQM shared more information this week, stating that “it is considered that the currently valid CEPs referring to these monographs are already in conformity with the requirements of the monographs and therefore remain valid.”
 
While there is no need for CEP holders to demonstrate conformity to the monographs, EDQM said they may choose to revise their control strategies for nitrosamine impurities in light of the updated information. CEP holders that change their strategies should request a minor revision.    
 
EDQM Statement
 
Fimea puts cooperation at heart of new regulatory strategy
 
The Finnish Medicines Agency (Fimea) has released a new strategy focused on development and cooperation, based on feedback from staff and stakeholders who were asked what the agency should be like in 2025 .
 
Through the consultation, Fimea identified a desire among staff to strengthen the diversity of the agency’s expertise and ensure the reliable production of information. External stakeholders put the emphasis on the flexibility, speed and customer service.   
 
“So our new strategy will focus on development, with the aim of incorporating the customer service perspective, strongly highlighted by our stakeholders, as part of Fimea's operations as a licensing and supervisory authority,” said Eija Pelkonen, Fimea director general.
 
A document outlining the strategy states Fimea will play an active role in national and international networks and pool its expertise to serve common objectives. In doing so, Fimea aims to produce new knowledge to support decision-making and discover new insights and innovative and sustainable practices.
 
Fimea shared the strategy shortly before issuing its 2020 accounts and annual report. The documents show Fimea met its profitability target amid pandemic-related disruption that led it to take actions such as the development of a model for remote inspections.
 
Fimea Notice, More
 
France’s ANSM forms expert committee to strengthen information on acne drug
 
The French National Agency for Medicines and Health Products Safety (ANSM) has formed an expert committee to consider actions that could improve the information on the acne drug isotretinoin.
 
In rare cases, isotretinoin, also known as Accutane, can cause serious side effects such as depression and suicidal thoughts. The risk of those side effects and other rare, serious adverse events have made the drug a focus of regulatory scrutiny. In the US, women must commit to use two forms of birth control to get a prescription due to the effect isotretinoin can have on babies.
 
ANSM formed a committee of healthcare professionals and patient representatives to assess how to communicate information about the risks in France. This week, the committee heard from patients, doctors, pharmacists and other stakeholders at a meeting convened by ANSM.
 
The committee used the meeting to gather proposals for how to improve access to information on isotretinoin, particularly with regards to the effects it can have on babies and mental health. ANSM is yet to share the recording of the meeting or communicate any findings or next steps.
 
ANSM Notice (French)
 
Other News:
 
Boehringer Ingelheim and GlaxoSmithKline have been sanctioned for promotions that brought discredit upon the pharmaceutical industry. The UK Prescription Medicines Code of Practice Authority (PMCPA) called Boehringer out over “a misleading claim” that Pradaxa could be used in any patient at increased risk of bleeding. PMCPA sanctioned GSK over a webinar registration page that promoted Relvar Ellipta and lacked prescribing information. The case is the second time in recent years that PCMPA has sanctioned GSK over an asthma webinar. PMCPA Notice

 

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