ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Step 2b

This new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The guideline strives to promote, for regulators (assessors and inspectors), an improved understanding of the Applicants’ pharmaceutical quality systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 guidelines.

Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container


Date for coming into effect 1 Oct. 2019

Guidance is provided on the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference ondition of the European Pharmacopoeia (Ph. Eur.) is the method of choice whenever possible, this guideline provides information on when other terminal
sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional post-aseptic processing terminal heat treatment), could be accepted as an alternative. Guidance is provided on the documentation expected for sterile finished products, sterile active
substances, sterile excipients and sterile primary containers (referred to as container in this guideline) in a new marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline).

EC / EUnetHTA – Harmonizing HTA Methodological Standards Across EU Member States

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.


WHOCC ATC/DDD Index 2019

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. 

EMA: Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products


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.

EMA gives guidance on safety monitoring of medicines used in children

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.