Quality guidelines: specific types of products
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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.
Guidelines
- Development and manufacture of synthetic peptides
- Development and manufacture of oligonucleotides
- Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)
- Pharmaceutical quality of inhalation and nasal products
- Quality of oral modified release products
- Quality of transdermal patches
- Radiopharmaceuticals
- Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
- 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
- Suitability of the graduation of delivery devices for liquid dosage forms
- Quality and equivalence of locally applied, locally acting cutaneous products