EMA: Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia

This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic ...

GMP: European Commission publishes Question & Answer Document on GDP

On 28 March 2014 the European Commission has published a new question and answers document which will clarify some frequent asked questions about the interpretation of the new EU GDP Guideline. ...

EMA: Guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products that contain modified proteins as active substance.

This guideline outlines the approaches to be followed for declaring the quantitative composition / potency labelling of medicinal products that include modified proteins as their active substance, ...

FDA: Draft Guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

This guidance is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human prescription drug and biological products for indications that are approved ...

EMA: Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins

The Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins, CHMP/BMWP/42832/2005 laid down general recommendations for the performance of a systematic immunogenicity ...

GMP: EMA publishes New Process Validation Guideline

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 ...

GMP: Detailed analysis of EMA\'s new Guideline on Process Validation

After the publication of the draft of Annex 15 at the beginning of February 2014 EMA now followed suit with the revision of its Guideline on Process Validation. The final document was published on ...

MHRA: Guidance on medical device stand-alone software (including apps)

The following guidance is for healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device. ...

FDA: Draft - Guidance for Industry Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current ...

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

A new guidance finalized by the US Food and Drug Administration (FDA) is meant to clarify which events and changes sponsors of new and generic drug products need to report in their annual reports ...

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