EMEA: Dossier requirements

It is presented dossier requirements for Post-authorisation submissions in the centralised procedure ...

MHRA: MLX 357 - Outcome of consultation on measures to strengthen the medicines’ supply chain and reduce risk from counterfeit medicines

This consultation sought your views on a number of proposals to improve the operation of the medicines’ supply chain in the UK. It also sought views on European Commission proposals to amend ...

FDA: Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs

As part of the cGMP initiative announced in August of 2002, and to help FDA be more transparent with cGMP policy, FDA has developed this question and answer resource on Current Good Manufacturing ...

FDA: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

The purpose of this guidance is to inform industry of how the FDA intends to comply with section 1111 of the Food and Drug Administration Amendments Act (FDAAA), which requires FDA to identify and ...

EMEA: Reflection paper Non-clinical and clinical development of similar medicinal products containing recombinant interferon alpha

This product specific reflection paper presents the current view of the CHMP on the non-clinical and clinical data for demonstration of comparability of two recombinant, non-pegylated, Interferon ...

EMEA: ICH E 16 Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissions

The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E151. Biomarker qualification ...

EMEA: ICH M 2 Questions and Answers - Common Technical Documents for the Registration of Pharmaceuticals for Human Use

This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification. The questions answered here relate to common ...

EMEA: ICH M 3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope ...

EMEA: ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Qualit Risk Management Pharmaceutical Quality System Questions and Answers

This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering ...

EMEA: ICH Q 4 B Annex 5 to Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapter

This annex is the result of the Q4B process for Disintegration Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

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