FDA: Draft Guidance - Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

This draft guidance is intended to assist spon sors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to ...

EMA: Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures

As the first step to market access, a new medicine requires a marketing authorisation from a medicines regulatory agency. The second step prior to enabling patient access to a new therapeutic ...

URPL: Guidelines concerning application and verification of correctness of umbrella segments in the names of medicinal products for human use

This document published by Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerns guidelines on application and verification of correctness of umbrella ...

EMA: Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template\"

The objective of this guidance and the Qualified Person (QP) declaration template is to emphasise the importance of providing a valid declaration, to harmonise the format for the declaration, to ...

EMA: Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

This 6th update of the guideline further clarifies specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and ...

RAPS: FDA Classifies Cellulite-Reducing Device as Class II

The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve \"the appearance of cellulite\" as Class II medical devices, making it ...

EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

The guideline addresses the requirements regarding manufacturing processes, the biosimilar comparability exercise for quality, considering the choice of reference medicinal product, analytical ...

RAPS: India Issues Final Rule on Compensating Clinical Trial Deaths

India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be ...

RAPS: FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes

The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted ...

EC: EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use

Volume 2 of the publications \"The rules governing medicinal products in the European Union\" contains a list of regulatory guidelines related to procedural and regulatory requirements such as ...

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