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  • Novidades 13 de Setembro de 2019 0

EC - EUROPEAN COMISSION

Pilot project ‘Market launch of Centrally Authorised Medicinal Products’

The Pharmaceutical Strategy for Europe highlights the importance of patients' access to medicines. Innovative and promising therapies do not always reach the patient and, in the EU, there are still different levels of access to medicines.

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

New FDA Guidance for COVID-19 Packaging Changes: Glass Vials and Stoppers

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

 

What is the FDA's Position on Concurrent Validation?

In the FDA Guidance for Industry on process validation, there is also a short section on concurrent validation. Concurrent validation should be used rarely, but may be possible if, for example, products are manufactured infrequently or medically necessary products are needed for short-term market supply. A recent Warning Letter underlines the guideline's statement that concurrent validation should be used rarely.

 

Medical Gases: WHO publishes Draft Guideline

In February 2021, the WHO published the new Guideline "GOOD MANUFACTURING PRACTICES FOR MEDICAL GASES" on the manufacture, testing, storage and distribution of medical gases for comment. The reason for the WHO to create this new guideline is the increased demand for oxygen for ventilation due to the Corona pandemic.

 

Questions & Answers on Good Distribution Practices (GDP) - Part 2

 

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 2 deals with questions related to the role of the Responsible Person for GDP.

 

Ph. Eur. Adopts New General Chapter on Contaminant Pyrrolizidine Alkaloids

The Ph. Eur. Commission adopted a new Ph. Eur. general chapter on contaminant pyrrolizidine alkaloids. The chapter will be implemented on 1 January 2022.

 

  

EDQM

 

Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation

The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the detection, management and prevention of the presence of N-nitrosamines in “sartan medicinal products” (see EMA news item of 13 November 2020).

 

  

EMA - EUROPEAN MEDICINES AGENCY

Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan and olmesartan , Article 31 referrals, European Commission final decision, 12/11/2020, 19/02/2021, 08/03/2021 (updated)

 

Referrals document: Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Questions & answers on implementation - Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products (new)

 

Brexit-related guidance for companies (updated)

 

International collaboration on GMP inspections (updated)

 

Brexit: the United Kingdom's withdrawal from the European Union (updated)

 

 

Report: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive - 2020 (new)

 

Agenda: CHMP ORGAM agenda for the meeting on 13 July 2020 (new)

 

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated)

 

List of medicines under additional monitoring (updated)

 

 

 

FDA

Coronavirus (COVID-19) Update: March 2, 2021 

 

  

GDP ASSOCIATION

 

Judgement of Federal Administrative Court of Germany on the Required Expertise of the Responsible Person for GDP

The Federal Administrative Court of Germany (Bundesverwaltungsgericht - BVerwG) has dealt with the question of what requirements are to be placed on the expertise of the Responsible Person for GDP. In a recently published judgment, the court has clarified that knowledge of pharmacy comparable to that taught in a pharmaceutical (vocational) training is not required. Rather, the knowledge can also be gained through practical experience.

 

European Anti-Fraud Office warns against Fraudsters Offering COVID-19 Vaccines

The European Anti-Fraud Office (Office européen de lutte antifraude - OLAF) has warned governments from dubious offers to provide them with COVID-19 vaccines.

 

Questions & Answers on Good Distribution Practices (GDP) - Part 2

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 2 deals with questions related to the role of the Responsible Person for GDP.

 

Questions & Answers on Good Distribution Practices (GDP) - Part 1

 In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 1 deals with questions related to GDP training.

 

 

HMA

(No new developments)

 

 

HMA - CMDH

NEW - Summary of risk management plan for dexamethasone for treatment of coronavirus disease 2019 (COVID-19) 

 

NEW - Summary of CMDh Activities 2020

 

UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP;

 

UPDATE - 'Blue-box' requirements.

 

 

ICH

The eCTD v4.0 Q&A v1.4 reaches Step 4 of the ICH process

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.4 reached Step 4 of the ICH process in December 2020.

 

 

INFARMED 

Áustria retira por precaução lote da vacina AstraZeneca

A Áustria suspendeu a distribuição de um lote da vacina COVID-19 da AstraZeneca, após terem sido recebidas duas notificações de reações adversas graves com um mesmo lote da vacina da AstraZeneca. 

 

Vacina BioNTech/Pfizer - ComiRNAty - Atualização à Circular Nº 007/CD/100.20.200

Tendo sido autorizada a introdução no mercado europeu da vacina Comirnaty, a 21 de dezembro de 2020, e tendo-se iniciado a campanha de vacinação contra COVID-19 em 27 de dezembro de 2020, atualizam-se as normas aplicadas à logística, distribuição e utilização desta vacina.

 

 

EFPIA

Maintaining the exchange of critical health data 

We welcome the draft adequacy decision on the UK data protection regime issued by the European Commission on 19th February 2021. Protecting the benefits of the free flow of personal data must be a top priority. The absence of an adequacy decision would negatively impact the UK and EU health sectors and their patients. We urge the European Data Protection Board and the European Parliament to support the ruling and National Governments to approve the draft decision.

 

 

DIA

(No new developments)

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