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  • Novidades 11 de maio 2020 0

EC - EUROPEAN COMISSION

 

Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies

 

Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies

The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan.

 

Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies

The purpose of the present templates is to guide manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report. This would assist manufacturers in a harmonised and complete presentation of post market clinical data and facilitate the activity of notified bodies and competent authorities in finding the information in an organized format.

A statement from the President on COVID-19

As President of Medicines for Europe, and someone who is directly involved in medicine production and supplynI want to be clear on the urgency surrounding Medicines for Europe’s main objective – to ensure supply andnavailability of medicines during this unprecedented public health crisis. Our industry looks at this in a number of different ways.

 

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

New Ph. Eur. Chapter on Essential Oils

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.

 

Remote Access to Critical GxP Systems by Service Providers

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: Must there be regulations for remote access by service providers to GxP-critical systems and what data integrity requirements must they contain? 

 

Update on COC / COP and Extractable Elements in Plastic Materials

Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.

 

FDA Warning Letter: Violations of GMP Fundamentals in Quality Control and Manufacturing Process

A Warning Letter was inevitable when FDA inspectors found that even basic GMP requirements were not being met at a Chinese production site.

 

Evidenced Cross-Contamination at Indian Manufacturer results in Warning Letter

The FDA has recently issued a Warning Letter to a large Indian pharmaceutical manufacturer following an inspection that revealed poor cleaning and later detected cross-contamination in manufactured tablets. Further GMP violations were detected like leaking HEPA filters and inadequate smoke studies in the sterile area.

 

FDA Warning Letter to EU Company

Despite the MRA, FDA is still coming to the EU to inspect. Now a company from Bulgaria received a Warning Letter and was placed on Import Alert.

 

EDQM 

The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information

The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.

 

 

EMA - EUROPEAN MEDICINES AGENCY

Scientific guideline: Q3C (R8) Step 2b - impurities guideline for residual solvents - Pde for 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol

 

ICH Q3C (R6) Residual solvents

This document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. It recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents

Suspension of ranitidine medicines in the EU

EMA’s human medicines committee (CHMP) has recommended the suspension of all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).

 

Guidance for medicine developers and companies on COVID-19

EMA, the European Commission and the national competent authorities published questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic. This guidance is for pharmaceutical companies responsible for veterinary medicines and sets out the adaptations to the regulatory framework in place to address challenges arising from the COVID-19 pandemic.

 

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2020 meeting.

 

EMA starts rolling review of remdesivir for COVID-19

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19).

 

Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic

The European Commission, EMA and the Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary (CMDv) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in order to address some of the constraints posed by the COVID-19 pandemic

 

 

 

FDA

 

(COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products

Today, the U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.

 

 

 

HMA - CMDH

 

March 2020 CMDh Minutes

 

Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (update)

 

Update of the guidance 28 April 2020

 

 

 

 

INFARMED

 

Infarmed lança infografias alertando para a importância da notificação de reações adversas em doentes com COVID-19

O Infarmed, no seguimento de uma ação de informação promovida pela Agência Europeia do Medicamento (EMA na sigla inglesa) à qual se associa, produziu duas infografias – uma dirigida aos cidadãos e outra aos profissionais de saúde – com o objetivo de alertar os doentes com doença COVID-19 (confirmada ou suspeita) e os profissionais que os acompanham, para a importância de notificar qualquer suspeita de reação adversa a medicamentos (RAM), estejam eles a ser ministrados no âmbito da COVID-19 ou sejam de toma habitual.

 

 

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