Guidance Tracker-All Guidances

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

Implementation strategy of ICH Q3D guideline

Concept paper on the revision of the ’Guideline on the environmental risk assessment of medicinal products for human use’ (EMEA/CHMP/SWP/4447/00 corr 2)

Concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’ (EMEA/CHMP/SWP/28367/07)

Botanical Drug Development

Contract Manufacturing Arrangements for Drugs: Quality Agreements

Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container

ICH Q3C(R9) Quality Guideline Maintainence EWG Maintainence of Guideline of Residula Solvents

Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

ICH Q3C(R9) QUALITY GUIDELINE Impurities: Guideline for Residual Solvents