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GMP: ICH publishes New Draft Guideline on Genotoxic Impurities

07.03.2013
The ICH has published a draft guideline for comment on the determination and the control of DNA reactive (mutagenic) impurities in medicinal products. The guideline is entitled: \"M7: Assessment ...

Polish Ministry of Health: Project regarding amendment of law - Pharmaceutical law and other regulations

28.02.2013
This document of Polish Ministry of Health concerns amendment of regulation - Pharmaceutical law and other regulations ...

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 ...

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 ...

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) ...

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 ...

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 ...

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) ...

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 ...

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 ...