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Scientific guidelines (human and veterinary)
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Last updated 4 days ago
Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products
4 days ago
Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products
Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)
4 days ago
Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled...
Draft information for the package leaflet regarding proline used as an excipient in medicinal products for human use
about 1 month ago
Draft information for the package leaflet regarding proline used as an excipient...
ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
about 2 months ago
ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
Preliminary QIG Considerations regarding Pharmaceutical Process Models
about 2 months ago
Preliminary QIG Considerations regarding Pharmaceutical Process Models
Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations
about 2 months ago
Draft guideline on allergen products development for immunotherapy and allergy diagnosis in...
Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline
2 months ago
Reflection paper on investigation of pharmacokinetics in the obese population - Scientific...
Guideline on the clinical evaluation of anticancer medicinal products - Revision 6
3 months ago
Guideline on the clinical evaluation of anticancer medicinal products - Revision 6
ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 5
3 months ago
ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from...
Draft guideline on the evaluation of the benefit-risk balance of veterinary medicinal products
4 months ago
Draft guideline on the evaluation of the benefit-risk balance of veterinary medicinal...
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
4 months ago
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers
5 months ago
Questions and answers on data requirements when transitioning to low global warming...