EMA: Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products

This concept paper addresses the need for a revision of the guidance on the selection of sterilisation methods currently provided for in the annexes to the (separate) human and veterinary ...

EMA: Guideline on stability testing for applications for variations to a marketing authorisation

This guideline provides guidance on the stability data which have to be generated in order to support a variation to a marketingnauthorisation. The guideline provides general guidance on stability ...

GMP: GMP Non Compliance Reports - Update in EMA Database

The EMA Database EudraGMDP is a major achievement for GMP and GDP compliance information. Since parts of the data are now publicly accessible, it makes it easier to get important information ...

FDA: Guidance - Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations

The purpose of this guidance is to describe the Agency’s current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and its ...

FDA: Guidance for Industry Immunogenicity - Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs

This draft guidance discusses immunogenicity - related approval considerations for low molecular weight heparin (LMWH) products. ...

FDA: Guidance for Industry CMC Post approval Manufacturing Changes To Be Documented in Annual Reports

This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. ...

GMP: WHO publishes revised draft on the Guideline on \"Hold Time\" studies

The key message of the Guideline has remained unchanged: manufacture in compliance with GMP requires the definition of hold times for intermediates and bulk products. The scope stated is the ...

GMP: FDA plans Changes to the Classification of Medical Devices

At the end of March, the FDA announced in the Federal Register that changes to 21 CFR 860 (Medical Device Classification Procedures) were planned. According to its risk class, a medical device ...

GMP: New FDA Guideline on Size, Shape and Physical Attributes of Generics

The FDA published a guideline draft entitled \"Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules\". The Agency saw a need for regulation because of the fact that the ...

EMA: The Revised Checking Process of Mock-Ups and Specimens of outer/immediate labelling and package leaflets in the Centralised Procedure for Veterinary Medicinal Products

The Agency operated an extensive checking process of the Marketing Authorisation Holder’s (MAH) printed materials for outer and immediate labelling of centrally authorised medicinal products as ...

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