News and updates on pharmaceuticals
Pharmaceuticals Archives - 2011
Implementing act on the requirements for the assessment of the regulatory framework applicable to the manufacturing of active substances of medicinal products for human use - Concept paper submitted for public consultation
Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act.
Delegated act on the detailed rules for a unique identifier for medicinal products for human use, and its verification - Concept paper submitted for public consultation
Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. This concept paper is being rolled out for public consultation with a view to preparing both the impact assessment and the delegated act.
"Handling of duplicate marketing authorisations applications" - Update
The document "Handling of duplicate marketing authorisations applications" has been updated. A new section regarding the classification of the scope of Article 82(1) of Regulation 726/2004 has been included. Prospective applicants are invited to consult the note prior to the submission of applications under Article 82(1).
Commission Call for Expression of Interest for the position of Member of the Management Board of the European Medicines Agency ('EMA') and for the position of Member of the following scientific committees of EMA: Committee for Advanced Therapies ('CAT'), Committee for Orphan Medicinal Products ('COMP') and the Pharmacovigilance Risk Assessment Committee ('PRAC')
The Management Board
This call for expressions of interest relates to the appointment of members to the Management Board of the European Medicines Agency (EMA) to represent patients', doctors' and veterinarians' organisations.
Documents (zip file)
This call for expressions of interest relates to the appointment by the Commission of members and alternates representing clinicians and patients' associations at the Committee for Advanced Therapies of EMA.
Documents (zip file)
This call for expressions of interest relates to the appointment by the Commission of members representing patients' organisations to the Committee for Orphan Medicinal Products of EMA.
Documents (zip file)
This call for expressions of interest relates to the Commission appointments to the new Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA). With this call the Commission is looking for:
• Representatives of healthcare professionals and patient organisations;
• Independent scientific experts .
Documents (zip file)
- With this call for expression of interest, the Commission wishes to invite all interested candidates to submit applications. Deadline 1 December 2011.
The deadline for submissions for representatives of healthcare professionals and patient representatives to the Pharmacovigilance Risk Assessment Committee (PRAC/11/PH) has been prolonged until 16 January 2012.
Public Consultation Paper on the review of Regulation (EC) 1234/2008 to the handling of variations to purely national marketing authorisations.
In 2006, the European Commission initiated an ambitious project to revise the overall framework for variations to make the whole system simpler, clearer and more flexible without compromising public health. The new regulatory framework on variations is the Commission’s main contribution to the ‘Better Regulation’ policy agenda in the field of pharmaceuticals. The final step to conclude the adoption of the variations’ initiative will be the amendment of Regulation (EC) No 1234/2008 to enlarge its scope to include purely national authorisations, in accordance with the mandate given by Directive 2009/53/EC.
With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on the following items:
(1) The extension of the scope of the Variations Regulation to purely national marketing authorisations.
(2) The adjustment of some of the procedures with a view to focus resources of the authorities on variations with the most impact on public health.
(3) Some workability concerns identified.
(4) Whether, in the light of the experience of last year, the procedure for the authorisation of vaccines in a pandemic setting should be amended.
It can be found here.
Responses to the public consultation on the concept paper on an “amendment of Commission Regulation (EC) 658/2007 concerning financial penalties for infringements committed by marketing authorisation holders of centrally authorised products”
The responses are published below. Overall, the Commission received nine responses. Four from public authorities, two from stakeholder associations and three from other groups, including consultancies, health professionals and private individuals. One private individual requested not to publish his contribution:
- AESGP – Association of the European Self-Medication Industry
- AFSSAPS – French competent authority for medicinal products
- Covington & Burling LLP
- Czech competent authority for medicinal products
- EFPIA – European Federation of Pharmaceutical Industries and Associations
- EMA – European Medicines Agency
- GMA – German Medical Association
The Paediatric Regulation (Regulation (EC) No 1901/2006 ) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals for children. The Commission is obligated to report on companies and products that have benefited from those rewards and incentives as well as on companies that have failed to comply with any of the obligations in the Regulation (Article 50(1) of the Regulation).
In this regard the European Medicines Agency has compiled a report covering the year 2010.
Pharmaceuticals: today, the EU Register of Clinical Trials is launched Online
From today, all EU citizens will have access to information on the thousands of authorised pharmaceutical clinical trials that are underway in the EU. The aim of this official public register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials. Every year approximately 4000 clinical trials are authorised in the EU. Since most of them last 2 to 3 years, this means that around 10 000 trials are ongoing at any given time.
Europa - Press releases Translations.
The clinical trials register: https://www.ClinicalTrialsRegister.eu
EudraLex - Volume 10 Clinical trials guidelines : updates
Guidance documents applying to clinical trials - Questions & Answers Document, Version 8.0 and Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs), rev.1 (March 2011)
Guidance documents applying to clinical trials - Questions & Answers Document, Version 8.0 (March 2011)
The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 8.0 of this document is available here .
Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs), rev.1 (March 2011)
This is a revision of the Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs), which had been published in 2007. The main change relates to point 3.3 and the additional annex 2 setting out documentation requirements for NiMPs in the application dossier. This revision completes the detailed guidance CT-1, which sets out the framework of a harmonised dossier requirements in the request for authorisation of a clinical trial to the national competent authority. The document is available here .
Standing Committee - Meeting report of the Standing Committee on Medicinal Products for Human Use, 17 February 2011
Public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC.
The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC. This concept paper is being put out for public consultation. It presents:
- a 'preliminary appraisal' of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and
- the main figures that are being used to evaluate the impacts of the different policy options.
Publication of the new pharmacovigilance legislation in the Official Journal
Following adoption by the Council and the European Parliament, the new legislation on pharmacovigilance was published on 31 December 2010 in the Official Journal of the EU. The new legislation, a Regulation and a Directive, will become applicable in July 2012.
Publication of revised GMP guidelines, chapter 4 and Annex 11 .
Today, DG SANCO launches the publication of revised GMP guidelines (chapter 4 on documentation and Annex 11 on computerised systems). The revised guidelines will come into operation on 30 June 2011.