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

EMA/CHMP/CVMP/QWP/850374/2015)

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).

Mehr Integrität und Transparenz im Heilmittelbereich/Plus d’intégrité et de transparence dans le domaine des produits thérapeutiques

Im Heilmittelbereich gelten ab 2020 neue Regeln für die Integrität und Transparenz. Der Bundesrat hat an seiner Sitzung vom 10. April 2019 neue Bestimmungen zum Heilmittelgesetz (HMG) verabschiedet. Bei verschreibungspflichtigen Arzneimitteln werden geldwerte Vorteile untersagt, wenn sie die Wahl der Behandlung beeinflussen können. Ausserdem müssen Preisrabatte und Rückvergütungen beim Heilmitteleinkauf künftig gegenüber den Behörden transparent gemacht werden. Mehr Information hier

RR DRA 2019 Jan/Feb Regional Roundtable Drug Regulatory Affairs

RR DRA took place at 3 alternative dates on 11 January (de), 18 January (de), 12 February (fr) 2019

47 regulatory professionals from 35 companies participated.  For the first time we had over 10 participants from 6 companies in the French group.

The participants had a lively and fruitful exchange of information how to handle the new guidances regarding the TPA Rev2 and its ordinances, which entered into force on 1 January 2019. Tips were given how to work pragmatically with the new forms. Questions about practical issues were submitted to Swissmedic, who were answered quickly.

Thanks to Katharina Oehler-Tomamichel, Doris Penna, Katja Starke and Stefanie Zaugg for their dedicated moderation and reporting.

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.