Consultations

This website provides hospital pharmacists with information on open consultations that are being conducted by EAHP, the European Medicines Agency, the European Commission and any other entities or individuals. 

EAHP 

No open consultation at the moment.

European Medicines Agency (EMA)

Due date Name of consultation  Scope of consultation
08/12/2021 ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – addendum The ICH M7 guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.
17/12/2021  Guideline on computerised systems and electronic data in clinical trials  Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last years. The EMA 'Reflection Paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials' started to address these when it was published in 2010. However, the development of and experience with such systems has progressed. A more up to date guideline is needed.
20/12/2021 ICH guideline Q13 on continuous manufacturing of drug substances and drug products This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.

It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.

European Commission

Due date  Name of consultation Scope of consultation
21/12/2021 Public Consultation: Revision of the EU general pharmaceuticals legislation This public consultation aims to collect views of stakeholders and the general public in order to support the evaluation of the existing general pharmaceutical legislation and the impact assessment of its revision. It builds further on the public consultation conducted for the preparation of the pharmaceutical strategy for Europe.

Others

Due date Name of consultation  Scope of consultation
15/12/2021 Questionnaire: Ward pharmacists in oncology   As part of her PhD project in clinical pharmacy, a member of the German Society of Hospital Pharmacists has put together a survey in order to demonstrate the benefits of a ward pharmacist in oncology and thus help to increase the patient's therapeutic safety. The project puts a specific focus on interprofessional collaboration of ward pharmacists, doctors and nursing in oncology.

To assess the impact of possible improvements and to get the most comprehensive picture possible, it is necessary to determine the current situation throughout Europe. For representative data collection, only one answer from each hospital pharmacy is allowed. Your information will be handled strictly confidential and the results will only be published anonymously. Participation only takes a few minutes and aims also at supporting pharmacists in clinics without a cytostatics department.

Last update: 23 November 2021