Aktualności
EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogen
28.02.2013
The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential
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FDA: Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements
28.02.2013
This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under 21 CFR 201.56(d) and
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FDA: Draft - Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers(R2)
28.02.2013
Although the ICH M3(R2) guidance is still in its early phases of the implementation, the complexity of the guidance, its broader scope, and numerous changes in recommendations from the M3(R1)
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GMP: Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline
28.02.2013
The new guideline is addressed to distribution organisations and distributors involved in the procuring, import, exporting, holding or supplying active substances. Re-packaging, re-labelling or
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EMA: Reflection paper on good-clinical-practice compliance in relation to trial master files (paper and / or electronic) for management, audit and inspection of clinical trials - Draft
21.02.2013
This reflection paper has been prepared to bring together the requirements of European Union (EU) legislation and guidance relating to the trial master file (TMF). This is deemed necessary by the
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EMA: Reflection paper on pharmacovigilance communication concerning veterinary medicinal products - Draft
21.02.2013
The experience gained by regulatory authorities has demonstrated the need and the benefits of streamlining and coordinating the communication process effectively within the European Union (EU)
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GMP: Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan
21.02.2013
Japan is an interesting market, also for medical devices. But in some parts the country is very different from Europe with regard to culture (writing, requirements concerning the appearance of
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GMP: FDA publishes List of planned Guidances for Medical Devices
21.02.2013
At the end of 2012 the Center for Devices and Radiological Health (CDRH) published a list with the Guidances planned for the fiscal year 2013 (1 October 2012 to 30 September 2013). The CDRH is the
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GMP: New Guidance for Recall of IMPs
21.02.2013
The European Commission DG Health & Consumers has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. Whereas the
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GMP: EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline
21.02.2013
Antimicrobial1 resistance (AMR) is an important issue to be addressed in applications for marketing authorisations of veterinary medicinal products (VMP) and related issues regarding animal
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