The European Commission recently launched a targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex Volume 4. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
Regulatory News- Quality and equivalence of topical products December 14, 2018
- Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation December 14, 2018
- Questions and answers on data integrity and compliance with drug CGMP December 14, 2018
- Biomarker qualification: evidentiary framework December 14, 2018
- Questions and answers on the ‘Deemed to be a Licence’ provision of the BPCI Act December 14, 2018
- Parliamentary News
- Activities of the European Ombudsman in 2017 December 14, 2018
- Employment and the pharmaceutical industry – Medical sales representatives December 11, 2018
- Costs of moving the European Medicines Agency to Amsterdam December 8, 2018
- Delays in plans to transfer the European Medicines Agency following the Brexit vote December 8, 2018
- European Medicines Agency December 8, 2018
