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EC - EUROPEAN COMISSION

(No new developments)

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

Non-Compliance Report for German Wholesale Distributor Published

The competent authority of Germany has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.

 

 

EDQM

EDQM published an updated section on the CEP affected by nitrosamines and the risk assessments conclusion on CEPs

The document can be found via following link.

 

 

Nitrosamines – Update from the CEP procedure

In June 2018, a manufacturer detected N-nitrosodimethylamine (NDMA) in valsartan active substance batches. This led to multiple regulatory actions addressing the presence of NDMA and other nitrosamine impurities, initially in valsartan but later extended to many other active substances. As 2020 draws to an end, the European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide a summary of the current situation with regard to nitrosamine impurities in substances covered by certifications of suitability to the European Pharmacopoeia monographs (CEPs).

 

New method for determination of polar N-nitrosamines in cosmetic products

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published an analytical method for the determination of polar N-nitrosamines in cosmetic products, which was validated within the European Network of Official Cosmetics Control Laboratories (OCCLs).

 

 

EMA - EUROPEAN MEDICINES AGENCY

Full assessment report available for first authorized COVID-19 vaccine

 

Human medicines European public assessment report (EPAR):

Comirnaty, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection, 21/12/2020, Authorised

 

COVID-19 vaccines: key facts (updated)

 

Transparency: exceptional measures for COVID-19 medicines

EMA is holding a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.

 

News and press releases: 

Cyberattack on EMA - update 3

 

Direct healthcare professional communication (DHPC):

GLOBAL RECALL: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion, Active substance: Ceftolozane, tazobactam, DHPC type: Quality defect, Last updated: 22/12/2020.

 

Referral: Ranitidine-containing medicinal products, ranitidine , Article 31 referrals, European Commission final decision, 17/09/2020, 24/11/2020, 22/12/2020 (updated) EMA confirms recommendation to suspend all ranitidine medicines in the EU.

 

Other: CHMP rules of procedure (updated)

 

Other: Timetable: Initial (full) marketing authorisation application (updated)

 

Other: Timetable: Extension application (updated)

 

Other: Timetable: Extension application - ATMP (updated)

 

Periodic safety update single assessment: Trandolapril / verapamil : List of nationally authorised medicinal products - PSUSA/00003005/202003 (new)

 

Periodic safety update single assessment: Ascorbic acid / paracetamol / pheniramine maleate : List of nationally authorised medicinal products - PSUSA/00002368/202003 (new)

 

Periodic safety update single assessment: Estradiol, estradiol /prednisolone : List of nationally authorised medicinal products - PSUSA/00010441/202004 (new)

 

 

FDA

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

 

 

GDP ASSOCIATION

Non-Compliance Report for German Wholesale Distributor Published

 The competent authority of Germany has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.

 

 

HMA

(No new developments)

 

 

HMA - CMDH

UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines;

UPDATE - Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure;

NEW - Report from the meeting held on 8-9 December 2020

 

United Kingdom's withdrawal from the European Union; Implementation of the European Commission Decision on the Art. 31 referral on ranitidine-containing medicinal products; CMDh practical guidance for MAHs of nationally authorized products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines;

 

 

ICH

Reflection Paper on Patient-Focused Drug Development for public consultation

ICH is conducting a public consultation on its ICH Reflection Paper on Patient-Focused Drug Development (PFDD), which was endorsed by the Assembly in November 2020. This Reflection Paper identifies key areas where incorporation of the patient’s perspective could improve the quality, relevance, safety and efficiency of drug development and inform regulatory decision making.

ICH Press Release: Continued Advancement in Global Harmonisation Efforts as ICH Prepares for 30 Year Commemoration.

 

 

INFARMED

(No new developments)

 

 

EFPIA – European Federation of Pharmaceutical Industries and Associations

Joint EU-UK pharmaceutical industry response to Brexit deal

We Won't Rest: Working together towards better patient outcomes

EFPIA and ITN Productions Industry News are co-producing an exciting new series of short films to explore how innovative science, partnerships and collaboration can improve the lives of patients across Europe. Each story takes a different perspective on connecting different actors and sectors of the research and healthcare eco-system to deliver more for patients.

 

 

EC – European Commission

(No new developments)

 

 

Others

eAF v1.24.0.1 now available

New version 1.24.0.1 of all four eAFs is now available to allow the users a short transitional period before the start of the mandatory use of the form. The changes in this version of the forms (v1.24.0.1) relate to the Member State, OMS and Country fields in all 4 forms and the changes are implemented due to the end of the transitional period following Brexit and in the view of the Northern Ireland protocol.

 

 

DIA – Drug Information Association

WHO works with UK as new virus strain prompts alarm

Vatic develops fast COVID-19 test

 

AstraZeneca vaccine may be approved in India next week

J&J finishes enrollment for Phase 3 COVID-19 vaccine trials

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