The 2018 European Commission proposal for regulation on HTA for assessing health technologies were adopted by the European Parliament’s Committee on the Environment, Public Health and Food Safety on 13 September 2018. The committee report was endorsed in plenary on 3 October 2018. The report proposes 200 amendments to the Commission proposal
The proposal covers new medicines and certain new medical devices. It focuses the future cooperation (the ‘joint work’) on assessing clinical aspects of HTA, namely: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem; the description and technical characterisation of the health technology; the relative clinical effectiveness and the relative safety of the health technology. Member States would continue to be responsible for assessing non-clinical (e.g. economic, social, ethical, organisational) aspects of HTA, as well as for making decisions on pricing and reimbursement.
EUnetHTA has already published 15 guidelines that form the basis of a framework for joint clinical assessment (JCA) methodologies in the EU. The main areas covered by these documents for pharmaceuticals include comparator selection, level of evidence, evidence synthesis, health-related quality of life (HRQL) and utility measures, internal validity of studies, personalized medicine, and methods for health economic evaluations.
Two further guidelines are in the pipeline.
A searchable version of the complete ATC index with DDDs 2019 is available here.
An update index 2019/2018 is available here
DDD: Classification with defined daily doses serves as an easing of comparisons between drugs and guarantees a standardised reference for the specification of daily treatment expenses.
This document sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on the safety features for medicinal products for human use.
Published by EC DG for Health and Food Safety
General consideration and guidance. This guidance should be read in conjunction with GVP module V. According to GVP module V, the aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product.
Revision of the European Pharmacopoeia General Monograph 2619 for Pharmaceutical Preparations which came into effect in January 2018, requires manufacturers of products outside the scope of the General Chapter 5.20 to control the levels of elemental impurities in the products using the principles of risk management. In the case of veterinary medicinal products, the scientific principles on which risk assessment/risk management should be based have not yet been elaborated as the permitted daily exposure (PDE) based approach detailed in General Chapter 5.20 and in ICH Q3D cannot be easily applied to veterinary products.
In order to allow time for regulators to elaborate guidance on the appropriate approach for a risk assessment for a veterinary medicinal product, the CVMP has adopted the following measured approach to the implementation of the monograph to existing veterinary products.
The staff and experts of the European Medicines Agency (EMA) publish articles on the Agency’s scientific activities in scientific publications, such as journals or textbooks.
Alteri E, Guizzaro L., Be open about drug failures to speed up research, Nature. 2018 Nov;563(7731):317-319
EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the paediatric population in the European Union.