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EMA: Draft proposal for an addendum, on transparency, to the \'functional specifications for the European Union (EU) portal and EU database to be audited\'

12.02.2015
This consultation document sets out proposals and options on the application of exceptions in relation to the transparency provisions of the European Clinical Trial Regulation. Once finalised, ...

GMP: USP Chapter <1790> Visual Inspection of Injections published

12.02.2015
The long-awaited USP Chapter regarding the 100% visual control of injectables has now been issued as a first draft in the Pharmacopeial Forum 41(1) for commenting. ...

FDA: Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

12.02.2015
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and ...

RAPS: Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

12.02.2015
The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic ...

EMA: Questions and answers on the withdrawal of the guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A), adopted

06.02.2015
The current guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A) [1] contains concise statements on the type of animal ...

EMA: Union procedure on sharing of pharmacovigilance inspection information

06.02.2015
Article 111(1) of Directive 2001/83/EC states that the competent authority of the Member State concerned shall ensure that the legal requirements governing medicinal products are complied with, by ...

EMA: Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus

06.02.2015
The aim of this guideline is to outline the procedure to be followed by the Competent Authorities when a batch of a vaccine is suspected to be contaminated with bovine viral diarrhoea virus ...

EMA: Reflection paper on the risk of antimicrobial resistance transfer from companion animals

06.02.2015
Antimicrobials are important tools for the therapy of infectious bacterial diseases in companion animals. Loss of efficacy of antimicrobial substances can seriously compromise animal health and ...

EMA: Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides

06.02.2015
Where it is considered that residues of pharmacologically active substances in biocidal products used in animal husbandry might have the potential to lead to consumer health concerns a consumer ...

RAPS: China Update: New Device GMPs and a World-First Vaccine Approval

30.01.2015
China’s Food and Drug Administration (CFDA) has issued revised current medical device good manufacturing practices (GMPs) that require manufacturers to implement quality management systems ...

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