• Regulatory NewsRegulatory News

    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
  • FDA Adopts ICH Guidance on Pharmaceutical Quality

    The US Food and Drug Administration (FDA) released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan. The guidance is co-sponsored by FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), both of which are in charge ...
  • Feature ArticlesFeature Articles

    East Africa Leads Medicine Registration Harmonization Thrust

    The East African Community (EAC), a regional intergovernmental organization of five member countries including Kenya, Uganda, Tanzania, Rwanda and Burundi, launched its Medicines Registration Harmonization (MRH) Project in March 2012. It was the first of the 12 Regional Economic Communities (RECs) and organizations (see Table 1 ) across the continent participating in the African Medicines Regulatory Harmonization (AMRH) Programme to do so. The launch of the project, wh...
  • EMA, PIC/S to Harmonize Good Manufacturing Practices for Pharmaceuticals

    The European Medicines Agency (EMA) on Wednesday, 11 June released additional documents expanding the extent of its cooperation with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), first announced in December 2010. PIC/S-composed of PIC and the PIC Scheme, which operate in tandem-works to promote inspection quality and cooperation among member counties, which include most European countries and, as of 2011, the US Food and Drug Administration (FDA). As of 20...
  • ICH to Minimize Role of Industry in Harmonization Process

    The International Conference on Harmonisation's (ICH) plans to implement changes to minimize the role of industry in its harmonization efforts going forward, making it the second international harmonization body this year to take efforts to exclude industry. In a 3 July statement, ICH said its Steering Committee and Expert Working Groups had "agreed on new principles of governance for robust science-based Guidelines for the review of the safety, efficacy, and quality of ...
  • ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 14 May it has established a concept paper and business paper for a new expert working group (EWG) aiming to develop guidance on rodent carcinogenicity testing. "The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clar...
  • New ICH Guideline on Periodic Safety Update Reports

    A new draft guideline put forth by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aims to "be a common standard for periodic benefit-risk evaluation reporting" for products marketed in ICH regions. The draft guidance, entitled E2C(R2): Periodic Benefit-Risk Evaluation Report ,  aims to "ensure that the periodic safety update reports for marketed drugs have the role of being periodic be...