RR DRA 2019 Jan/Feb Regional Roundtable DrugRegulatory 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. 

23. SwAPP/sgpm Annual meeting Pharmaceutical Medicine – Data Integrity – How to Trust and Protect Your Data

Information,  programme and photos see here

The symposium started off under a simple title: Data integrity. Two words.
At the end of the day everyone knew how wide and complex the topic is. It concerns the planning of one’s data, the controlling, protecting, maintaining, storing, analysing and sharing of data.
In the introductory talk, it was pointed out that data integrity does not only concern the health care sector, but other areas like financial flows, government data etc.
The next talk was about artificial intelligence, and how important it is to make a system learn the right things – it’s not about the weather, but about recognising the tank behind the tree! The talk also mentioned the challenges of interoperability and data sharing.
In the next talk, there was a change of subjects to pearl necklaces and the challenges of protecting a necklace. The speaker focused on different protection systems and protection levels and on risk management.
The next presentation addressed the regulations, the obligations of the data owners, and touched upon issues that are focused on in audits and inspections.

After a breathtaking piano intermezzo by Mischa Cheung,
the first talk in the afternoon focused on forensic technologies and on what happens if a theft of intellectual property or a breach of data integrity has taken place.
Then the challenges of a highly digitalised country, Estonia, were highlighted and Block Chain technology explained. It was made clear that a block chain is essentially a pin onto which sheets of paper with events are stacked.
The next talk addressed an issue in pharmaceutical medicine, namely medication fraud and medication verification, serialisation and the joint protection initiative.
Finally, the last two presentations focused on patient data: digitalised healthcare, digitalised clinical trial management and recruitment, and digital health consumers as well as the challenges, the willingness and the impact of sharing patient data.

In the name of both associations, SwAPP and sgpm, we thank the speakers for sharing their work, know-how, thoughts and time with us. We also thank the scientific organisers, the chairs and the event organiser. A special thanks to our sponsors. Without them, the symposium would not be possible. And last but not least a thank you to the interested audience for their active participation in the symposium.

Save the date and join us for our next symposium on the last Wednesday in November 2019: November 27, 2019. /ME

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.