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  • Novidades 16 de Outubro de 2019 0

EC - EUROPEAN COMISSION

(No new developments)

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

EMA confirms full functionality of CTIS - on track to go live January 2022

(update)

Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.

 

APIC: Update of the "Cleaning Validation" Guide for APIs

The new version of the document "GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS" was finalised in February 2021 and is now available on the APIC website.

 

 

 

EDQM

 

Risk of presence of mutagenic azido impurities in sartan active substances with a tetrazole ring

Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested.

 

Subscriptions now open for the European Pharmacopoeia 10th Edition Supplements 10.6-10.8

The 2022 subscriptions to the European Pharmacopoeia (Ph. Eur.) are now available for sale on the EDQM WebStore.

 

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete the test for “heavy metals” (HMs, general chapter 2.4.8) in monographs on substances “for veterinary use only”. The 16 monographs concerned have been published in Pharmeuropa 33.2 together with other new texts and technical revisions of the Ph. Eur. The deadline for comments is 30 June 2021.

 

 

 

EMA - EUROPEAN MEDICINES AGENCY

Medicines under additional monitoringList of medicinal products under additional monitoring (updated)

Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, 6, Authorised (updated)

 

Nitrosamine impurities (updated)

 

COVID-19 treatments: under evaluation (updated)

 

News and press releases: EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen

 

Guidance on good manufacturing practice and good distribution practice: Questions and answers (updated)

 

Other: Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs

 

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021

 

News and press releases: EMA working on COVID-19 during closure on 27 April 2021

Although the European Medicines Agency's (EMA) offices will be closed from 18:30 on Monday 26 April until 07:30 on Wednesday 28 April 2021, remote working is still being enabled.

 

Medicines for use outside the European Union (updated)

 

Agenda: Agenda - PDCO agenda of the 20-23 April 2021 meeting

 

Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia, Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021

 

Other: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMBASE (updated)

 

Summary of product characteristics for anthelmintics (updated)

 

Scientific guideline: Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics

 

Report: Applications for new human medicines under evaluation by the CHMP: April 2021

Health technology assessment bodies (updated) & Minutes

 

 

FDA

Coronavirus (COVID-19) Update: April 27, 2021

As part of the FDA’s effort to protect consumers, the agency issued a warning letter to an operator of one website, www.pharmacygeoff.md for marketing unapproved drugs for multiple diseases, including COVID-19.

 

 

GDP ASSOCIATION

 

GDP Non-Compliance Report for Romanian Wholesale Distributor

The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.

 

 

 

HMA

(No new developments)

 

 

 

HMA - CMDH

 28 April 2021

UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

 

 

 

ICH

 

The ICH Q3C(R8) Guideline reaches Step 4 of the ICH Process

The ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether and Tertiary Butyl Alcohol, reached Step 4 of the ICH Process in April 2021.

 

 

INFARMED

 

Novo regulamento sobre notificação prévia de transações de medicamentos para o exterior do país

Foi publicada1 a Deliberação n.º 391/2021, de 19 de março, que aprova o novo regulamento sobre notificação prévia de transações de medicamentos para o exterior do país. Este novo regulamento visa assegurar a disponibilidade dos medicamentos e melhorar o procedimento de revisão da lista de notificação prévia (LNP) para que esta reflita melhor o estado do abastecimento do mercado

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