Blog Category: Biopharma

ICH Guideline E8 (R1) on General Considerations for Clinical Studies

October 21, 2021
Standards

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those...

Center for Drug Evaluation and Research, Clinical studies of medical interventions, ich e8 general considerations for clinical studies, ich e8 guidelines

Switch of the legal status of a medicinal product from prescription to non-prescription – Romania

October 18, 2021
Medical Device

Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription to non-prescription – Romania Principles and procedures: • It is to the applicant to...

Medical product, Prescription to non-prescription, principles for a switch of the legal status, switch of the legal status

Registration of Drug-device Combination Products

October 8, 2021
Standards

NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products With the view to strengthening registration management of drug-device combination products, in accordance with...

combinationproduct, drug, medicaldevice, NMPA, registrationofdrug, registrationondevice

ICH: Guideline on Testing for Carcinogenicity of Pharmaceuticals, an Addendum

August 30, 2021
Biopharma

Over the course of drug development, it is important for sponsors to develop a scientifically robust strategy for carcinogenicity assessment that considers key biologic, pharmacologic, and toxicologic...

Addendum, Guideline on Testing for Carcinogenicity, Pharmaceuticals, Testing for Carcinogenicity of Pharmaceuticals

ICH E6 Good Clinical Practice Principles

June 30, 2021
Standards

The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial...

Clinical practice, Good clinical practice guidelines India, ICH E6 Guidelines for Good Clinical Practice, ICH GCP principles, ICH good clinical practice principles

Adverse Reaction Reporting Guide for New Zealand

June 2, 2021
Standards

New Zealand tends to have a high rate when it comes to adverse reaction reporting. The Centre for Adverse Reactions Monitoring (CARM), Dunedin acts as the national repository. This entire data helps...

adverse drug reactions, centre for Adverse Reactions monitoring, guide for adverse reaction reports, pharmacists.