Quality: specific types of products
The European Medicines Agency's scientific guidelines on specific types of products help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Scientific guideline
- Pharmaceutical quality of inhalation and nasal products - Scientific guideline
- Quality of oral modified release products - Scientific guidelines
- Quality of transdermal patches - Scientific guideline
- Radiopharmaceuticals - Scientific guideline
- Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Scientific guideline
- Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need - Scientific guideline
- Suitability of the graduation of delivery devices for liquid dosage forms - Scientific guideline
- Quality and equivalence of topical products - Scientific guideline
- Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) - Scientific guideline
- Establishment of a guideline on the development and manufacture of synthetic peptides - Scientific guideline
- Establishment of a guideline on the development and manufacture of synthetic oligonucleotides - Scientific guideline
- Development of CHMP guideline on dosing delivery of injectable liquids - Scientific guideline