NOTICIAS

EudraVigilance – EVWEB User Manual

EudraVigilance – EVWEB User Manual

This user manual is part of the official documentation prepared by the European Medicines Agency to support the use of the  EudraVigilanceWebreportingtool (EVWEB). The user manual consists of 5 chapters. Chapter 1 presents a comprehensive overview of the EVWEB...

EU MDR/IVDR News  (Harmonised Standards)

EU MDR/IVDR News (Harmonised Standards)

The European Commission has published two Implementing Decisions regarding medical device harmonised standards. "Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for...

ICH Q14 Analytical procedure development – Scientific guideline

ICH Q14 Analytical procedure development – Scientific guideline

  This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release...

The ICH Q3C(R9) Guideline reaches Step 4 of the ICH Process

The ICH Q3C(R9) Guideline reaches Step 4 of the ICH Process

The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024. This minor revision was implemented to include consideration of solvent volatility for analytical methods....

Charging for Investigational Drugs Under an IND: Questions and Answers

Charging for Investigational Drugs Under an IND: Questions and Answers

This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment...

EUDAMED user guide Economic Operators – Actor module

EUDAMED user guide Economic Operators – Actor module

  EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a...

Launch of new HMA-EMA catalogues of real-world data sources and studies

Launch of new HMA-EMA catalogues of real-world data sources and studies

15 February 2024 EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one forWD studies. The catalogues help medicines regulators, researchers and pharmaceutical companies to identify...

EU MDR Transition –Recalls and market notifications

EU MDR Transition –Recalls and market notifications

TGA have been published new document very helpful and interesting about EU MDR Transition –Recalls and market notifications Case studies and scenarios Version2.1,February2024   Introduction This guidance covers case studies and scenarios about recalls and market...

EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible,...

Use of Data Monitoring Committees in Clinical Trials

Use of Data Monitoring Committees in Clinical Trials

This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee...

Conducting Remote Regulatory Assessments Questions and Answers

Conducting Remote Regulatory Assessments Questions and Answers

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking...

UPDATED Glossary of ICH terms and definitions

UPDATED Glossary of ICH terms and definitions

  Version 5, 7 February 2024 -- This glossary combines the terms and definitions included in the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It was compiled by CIOMS from the...

What to expect from medtech in 2024

What to expect from medtech in 2024

The medtech industry posted an uneven year in 2023. Among the reasons for celebration were expectation-beating revenue growth, a record number of novel-product approvals, and a spate of divestitures that helped companies refocus on their core capabilities.   On...

New EU MDCG Guidance on Medical Device Vigilance Requirements

New EU MDCG Guidance on Medical Device Vigilance Requirements

A large release of the Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website: MDCG 2024-1, MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, and MDCG 2024-1-4. Each guidance falls into the “Device Specific...

Guidance International Recognition Procedure

Guidance International Recognition Procedure

From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP. ECDRP and MRDCRP...

What to expect in US healthcare in 2024 and beyond

What to expect in US healthcare in 2024 and beyond

A new perspective on how technology, transformation efforts, and other changes have affected payers, health systems, healthcare services and technology, and pharmacy services   The acute strain from labor shortages, inflation, and endemic COVID-19 on the...

FDA Quality and Compliance (Medical Devices)

FDA Quality and Compliance (Medical Devices)

The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating the international standard specific for...

Overview of language requirements for manufacturers of medical devices

Overview of language requirements for manufacturers of medical devices

The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and...

New MDCG Jan. 2024 Post-Market Surveillance and Vigilance (PMSV).

New MDCG Jan. 2024 Post-Market Surveillance and Vigilance (PMSV).

  Five new mdcg files read the full thread. 1. MDCG 2024-1 Guidance on the vigilance system for CE-marked devices Source: https://lnkd.in/gKC3KPaD 2. MDCG 2024-1-1 DSVG 01 on Cardiac ablation Source: https://lnkd.in/gKM9RuCH 3. MDCG 2024-1-2   Guidance on the...

EU MDR/IVDR News!! (Eudamed and IVDR Extension)

EU MDR/IVDR News!! (Eudamed and IVDR Extension)

Today (23-Jan) the European Commission has published a Proposal for "Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption...

Major update of the SME user guide

Major update of the SME user guide

The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development,...