GMP: APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants

An APIC multinational working group has compiled a new guidance on cleaning validation with the title \"APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients ...

EC: EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use

Volume 6 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 ...

EMA: European Medicines Agency selects first two medicines to be included in its adaptive licensing pilot project

The European Medicines Agency has received 20 applications so far as part of its adaptive licensing pilot project. Following an in-depth review of nine of these applications, the Agency has ...

GMP: Authority uses Margin of Interpretation regarding Qualification as QP

The Danish Health and Medicines Authority (DHMA) has published a document which shows that the EU has left enough leeway for the implementation of EU directives. This could be an option in other ...

RAPS: FDA Adopts, Releases ICH Document on Dose Uniformity

The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation\'s (ICH) Q4B guideline on the use of ...

Polish Ministry of Health: The Regulation of Polish Minister of Health of April 18, 2014 concerning detailed manner of presenting the dossier for application for marketing authorization of the medicinal product

This document is a regulation of Polish Minister of Health concerning the detailed manner of presenting the dossier for application for marketing authorization of the medicinal product. Full text ...

FDA: Draft Guidance - Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

This draft guidance is intended to assist spon sors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product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

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