2012/02/10
EC: information to patients and Pharmacovigilance - New developments
On 10 February 2012, the EC adopted an amended Commission proposal for a Directive as regards information to the general public on medicinal products subject to medical prescription, an amended Commission proposal for a Regulation as regards information to the general public on medicinal products subject to medical prescription, a Commission proposal for a Directive as regards Pharmacovigilance and a Commission proposal for a Regulation as regards Pharmacovigilance. See Link

2012/02/01
EC: responses to the Public consultations on the concept paper on implementing measures for the performance of pharmacovigilance activities and on the "Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use"
The EC published the responses received to the Public consultations on the concept paper on implementing measures for the performance of pharmacovigilance activities and on the "Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use". See Link

2012/01/20
EU: delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use - concept paper submitted for public consultation
Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use. See Link

2012/01/05
CMDh: Worksharing on Article 45
The CMDh released the updated list of the active substances included in the work-sharing procedure and the updated list of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation (December 2011). See Link

2011/12/22
EMA: rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures
The EMA has published the Rules for the implementation of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures as last adopted by the Agency’s Management Board on 15 December 2011. The Agency will apply the fees and definitions indicated in the document as of 1 January 2012. See Link

2011/12/21
EMA: fee reductions for designated orphan medicinal products
The fee reductions for designated orphan medicinal products were last revised by the European Medicines Agency on 1 April 2011, in line with the funding received through the special contribution from the EU. The Executive Decision on fee reductions was revised again on 16 December 2011 in order to inform on reductions applied to pediatric-related protocol assistance. See Link

2011/12/20
EMA: Regulatory Q&A on herbal medicinal products
The EMA has released an updated version of a document from the Committee on Herbal Medicinal Products (HMPC) related to regulatory questions and answers on herbal medicinal products. See Link

2011/12/09
EMA: European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections

The EMA and the FDA are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate. The initiative will apply to inspections of manufacturing sites of human or veterinary medicines in the European Economic Area or United States of America. It will focus on sites that are already known to the two authorities and have a history of compliance with good manufacturing practice (GMP) following previous inspections. See Link

2011/12/07
EC: 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 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 until 23 March 2012 with a view to preparing this implementing act. See Link

2011/12/01
EMA: guide to the European Medicines Agency
The EMA released an updated version of its guide to the various Units, Sectors and Sections at the Agency. It gives the names of the Heads of Unit, Heads of Sector and Section Heads. It also gives a general description of what each Unit does within the Agency. See Link