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  • Novidades 19 de Fevereiro de 2020 0



(no new developments)





Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.



FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.



Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs

FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.



Information on the Medical Devices Regulation

The application of the Medical Devices Regulation (2017/745, MDR) as of 26 May 2020 is approaching. Find out more about the MDR environment.



How to authorize a Combination Product in the USA?

In the USA, combination products are regulated independantly.  A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.



When does the FDA announce the Inspection of a Medical Device Manufacturer?

With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.



ICH E9 Addendum adopted

The ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.




Final Guideline on GCP for ATMPs published

The European Commission has now published the final Guideline GCP for ATMP as a further building block of its growing guidance package on  the requirements for Advanced Therapy Medicinal Products.



New GMP Guidance for Marketing Authorisation Holders

After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.






European Pharmacopoeia revises general chapter on degree of coloration of liquids

At its 165th session in November 2019, the European Pharmacopoeia Commission adopted a new version of one of its widely used general methods, chapter 2.2.2. Degree of coloration of liquids, which has been extensively revised to include the instrumental method. The revised chapter will be published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, available in July 2020.



Pharmeuropa Volume 32 No 1, January 2020

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.1 before 31 March 2020.



Shipment to China

Due to the coronavirus situation, the EDQM is experiencing issues in shipping reference standards to China. As the situation changes quickly, the EDQM contacts all concerned users in order to agree on the best possible option.



Ph. Eur. Supplement 10.2: CEP holders are invited to update their...

Supplement 10.2 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of July 2020, and to follow the instructions given in the document.



European Pharmacopoeia welcomes its 39th member state, Albania

On 9 February 2020, the Convention on the Elaboration of a European Pharmacopoeia entered into force in Albania, making the quality standards for medicines published in the European Pharmacopoeia (Ph. Eur.) legally binding throughout the country.





Mutual-recognition, decentralised and referral product-information template version 4.1 (update)



Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020

Following a review of the risk of meningioma (a rare tumour of the membranes covering the brain and spinal cord) in patients taking cyproterone, EMA’s safety committee (PRAC) has recommended that medicines containing 10 mg or more of cyproterone should only be used for hirsutism (excessive hair growth), androgenic alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed.



Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 14/02/2020

EMA’s safety committee (PRAC) has recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher doses have started working, the dose should be gradually reduced to the lowest effective dose.



Labelling-exemption requests under Article 63 of Directive 2001/83/EC examined by the Quality Review of Documents group

See also "Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure" document.



Pre-authorisation guidance

These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.






FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies.






(No new developments)






Minutes from the CMDh meeting with Interested parties - 13 November 2019



UPDATE - Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing


Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure.



UPDATE - 'Blue-box' requirements



CMDh annotated QRD template for MRP/DCP;






The United Kingdom has formally left the European Union on 31 January 2020 and has become a third country to the EU.

On 1 February 2020 a transition period has started which is due to end on 31 December 2020. During the transition period, EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ will continue to be applicable to the UK, meaning that pharmaceutical companies can continue to carry out activities in the UK until the end of the year.



Report from the meeting held on 28-30 January 2020

United Kingdom's withdrawal from the European Union






ICH S5(R3) reaches Step 4 of the ICH Process

The ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020.






Aviso de segurança para a correta utilização do sistema de monitorização contínua da glicemia Dexcom G4 Platinum

O dispositivo médico de monitorização contínua da glicemia Dexcom G4 Platinum, do fabricante Dexcom, Inc., apresenta vários ícones que se destinam a transmitir informações ao utilizador e que são descritos nas instruções de utilização. Alguns desses ícones são acompanhados de sinais sonoros, enquanto outros não.



Atualização da lista de grupos homogéneos e preços de referência

No âmbito do Sistema de Preços de Referência, a lista dos grupos homogéneos e dos preços de referência unitários, a vigorar no 1.º trimestre de 2020, foi atualizada.



Formulário eletrónico para avaliação da presença de nitrosamina em medicamento

Conforme descrito na Circular Informativa n.º 145/CD/100.20.200 de 27/09/2019, os titulares de Autorização de Introdução no Mercado (TAIM), como medida de precaução, têm de efetuar a revisão dos medicamentos que contêm substâncias ativas sintetizadas quimicamente para verificar a presença de nitrosaminas e testar todos os medicamentos com potencial risco, reportando, em ambos os casos, os resultados às autoridades nacionais competentes.



Medicamentos contendo valproato e ácido valpróico

Devido ao risco de malformações no feto e problemas de desenvolvimento nas crianças após o nascimento, têm vindo a ser implementadas diversas medidas para evitar a exposição intrauterina aos medicamentos contendo valproato ou substâncias relacionadas.



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