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.

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

Reflection paper

• Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)

Concept paper

• Development of CHMP guideline on dosing delivery of injectable liquids