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Scientific guidelines (human and veterinary)

Get the latest updates from Scientific guidelines (human and veterinary) directly as they happen.

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Latest posts

Last updated 17 days ago

Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

17 days ago

Reflection paper on use of real-world data in non-interventional studies to generate...

Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

17 days ago

Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure

Guideline on stability testing for applications for variations 4 to a marketing authorisation for veterinary medicinal 5 products

18 days ago

Guideline on stability testing for applications for variations 4 to a marketing...

Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products

18 days ago

Guideline on stability testing for applications for variations to a marketing authorisation...

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

about 1 month ago

Draft guideline on good agricultural and collection practice (GACP) for starting materials...

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

about 1 month 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)

about 1 month 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

2 months 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

3 months ago

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Preliminary QIG Considerations regarding Pharmaceutical Process Models

3 months ago

Preliminary QIG Considerations regarding Pharmaceutical Process Models