The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...

Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...

This article provides an overview of the international and national guidelines associated with clinical trials. The authors highlight the importance of multiregional clinical trials and outline the principles of good clinical practice (GCP) and regulatory compliance.   Introduction Clinical trials are essential components of pharmaceutical research and development. A clinical development program’s broad aim is to treat a specific indication in a certain population to...

Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical practice (GCP) requirements for these complex and innovative products that can include gene and cell therapies. The 15-page guidelines discuss clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and admini...

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT). FDA said in a letter sent to the company in late July that it has not yet submitted its pediatric assessment, which was identified in the BLA’s approval letter fro...

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan. The training programs are part of a pilot initiative agreed to at ICH's management committee meeting in Osaka, Japan in November 2016, where members of the management committee launched the year-long pilot and set out criteria for the program. Under the pilot, the ICH Training Subcommittee has partnered with a small group of training p...

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections. Among other expectations for the coming year, the EMA’s GCP Inspectors Working Group will develop new and revised guidelines on the redaction of inspection reports to protect personal data and commercially confidential information, as well as ...

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday. New members approved at the meeting were Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the US industry group Biotechnology Innovation Organization (BIO) and Korea’s Ministry of Food and Drug Safety (MFDS). In terms of observers, ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. CHMP Starts Review of Drugs Tested at Indian Sites Amid GCP Concerns The Committee for Medicinal Products for Human Use (CHMP) has begun a review of drugs tested at two Micro Therapeutic Research Labs’ sites in India. National regulatory agencies asked CHMP to run a review after Austrian and Dutch authorities found fault with the sites during a good clinical practice (...

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...

France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries. In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site. In particular, the inspectors highli...

The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India. In light of the issues, EMA says that studies conducted by Alkem at the facility between March 2013 and March 2015 cannot be relied on to support marketing authorizations. The recommendations stem from a review EMA launched i...