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)

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

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

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

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

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

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 ...

GMP: New Guidance for Recall of IMPs

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 ...

GMP: EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline

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 ...

EC: Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use - Draft

These guidelines provide guidance on how to asses and rank the risk presented by the excipient, cover identification on appropriate GMP and assesment and present guidance on how to manage the ...

EC: Guidelines on the principles of good distribution practices for active substances for medicinal products for human use - Draft

For the purpose of these guidelines, the distribution of active substances for medicinal products for human use (hereafter \'active substances\') is the procuring, import, holding, supplying or ...

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