EN PL

News

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 ...

EMA: European Union individual case safety report (ICSR) implementation guide

30.01.2015
This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs ...

FDA: S10 Photosafety Evaluation of Pharmaceuticals

30.01.2015
The purpose of this guidance is to recommend international standards for photosafety assessment, and to harmonize such assessments that support human clinical trials and marketing authorizations ...

RAPS: FDA\'s New Approach to Regulating Medical Device Accessories

30.01.2015
The US Food and Drug Administration (FDA) has outlined a new framework for classifying and approving medical device accessories, making clear that device accessories can be brought to market more ...

EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 4

15.01.2015
The guideline applies to new finished drug products (as defined in ICH Q6A and Q6B) and new drug products containing existing drug substances. The drug products containing purified proteins and ...