Aktualności
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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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
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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
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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
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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
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GMP: ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials
15.01.2015
The ICH Q11 Guideline entitled \"Development and Manufacture of Drug Substances\" from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the
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EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 on electronic common technical document (eCTD) - file format criteria - Step 5
15.01.2015
ICH M2 EWG pursued the challenging task of recommending international solutions by identifying the key areas (domains) that demanded M2\'s immediate attention. ICH M2 EWG concluded that the best
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RAPS: China May Soon Allow Online Drug Sales
15.01.2015
Regulators in China are looking to allow online sales of prescription medicines starting in early 2015, according to Reuters. A senior healthcare policy worker told the publication the China Food
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EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
15.01.2015
The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/05 Rev.1) lays down the
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EMA: Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs)-draft
08.01.2015
This guideline outlines the data requirements to be submitted by the marketing authorisation holder (MAH) to introduce a heat treatment to inactivate retroviruses in the active substance for the
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