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MHRA: Public consultation (MLX 363): Fees legislation for 2012

22.12.2011
This consultation seeks your views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homeopathic medicines, and blood ...

EMA: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

15.12.2011
Article 5(10) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires sponsors to submit annual reports on the state ...

EMA: Qualification opinion of low hippocampal volume (atrophy) by MRI for use in clinical trials for regulatory purpose - in pre-dementia stage of Alzheimer’s disease

15.12.2011
The European Medicines Agency’s (EMA) qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice of novel methodologies on innovative ...

EMA: Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1

15.12.2011
The objective of CTD Module 2.7.1 is to summarize all relevant information in the MAA dossier with regard to biopharmaceutic studies and associated analytical methods. This Appendix contains a ...

GMP: New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

15.12.2011
On 18 November 2011, the European Commission published a concept paper entitled \"Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its ...

MHRA: Public Consultation (MLX 374): Transposition of Pharmacovigilance Directive 2010/84/EU

15.12.2011
Consultation MLX374 seeks your views on the draft regulations transposing the EU Directive 2010/84/EU on Pharmacovigilance. This Directive must be transposed to UK law by 21 July 2012. This is ...

FDA: Draft Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designations

15.12.2011
Comments and suggestions regarding this draft document should be submitted within _90_ days of publication in the Federal Register of the notice announcing the availability of the draft guidance. ...

FDA: Regulatory Classification of Pharmaceutical Co-Crystals

07.12.2011
This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research’s current thinking on the ...

GMP: New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

07.12.2011
On 18 November 2011, the European Commission published a concept paper entitled \"Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its ...

EMA: Fees for type IA variations to be due at start of procedure

07.12.2011
The European Medicines Agency is informing marketing-authorisation holders that from 1 January 2012, fees for type IA variations will be due at the start of the 30-day procedure ...

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