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Mar 4, 2018

General Court confirms EMA approach to transparency
Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines

The General Court delivered three landmark rulings for the European Medicines Agency (EMA), upholding EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation”.

This is the first time that the Court of Justice of the European Union has had the opportunity to pronounce itself on the application of the Transparency Regulation to documents held by EMA.

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USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA

The United States Food and Drug Administration has issued the ICH E6R2 guidance for industry this March.

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USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings

These slides provide annual inspection metrics for the compliance programs overseen by the Office of Scientific Investigations (OSI) and the Office of Study Integrity and Surveillance (OSIS) in FDA’s Center for Drug Evaluation and Research (CDER). The vast majority of these inspections are conducted by FDA’s Office of Regulatory Affairs (ORA).

As FDA’s approval decisions are based on a review of the data submitted by an applicant, it is essential to ensure the integrity of the data submitted and to verify that the rights, health and welfare of those who participated in the studies were protected and that applicants continue to meet their obligations (e.g., for safety reporting) after approval. On-site inspection is one of many tools the FDA has for ensuring the integrity of data, the health and welfare of research participants, and the protection of public health.

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USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials

Since the ICH guidance Q11 Development and Manufacture of Drug Substances (ICH Q11) was finalized, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials.

This question-and-answer (Q&A) document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for the selection and justification of starting materials and of the information that should be provided in marketing authorization applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

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China’s CDE clarifies NDA dossier requirements
A wave of PD-1/PD-L1 mAb application pushes CDE to act

The CFDA's Center for Drug Evaluation (CDE) released a guidance document setting out basic requirements for New Drug Application (NDA) filings in relation to programmed death-1/ligand-1 (PD-1/PD-L1) monoclonal antibody (mAb) products. A wave of 16 PD-1/L1 candidates are currently under clinical development for the China market, with NDA filings in recent weeks for Bristol-Myers Squibb’s nivolumab, Innovent Biologics’ sintilimab, and Merck, Sharp & Dohme’s pembrolizumab.

The CDE drew up the guidance on the basis of a recent industry seminar, and the rules indicate a cautious approach will be taken. At least two independent assessments of safety and efficacy data for all patients enrolled in the study should be included in the initial dossier. Rolling submissions of data will be employed during NDA review, with at least 6 months’ efficacy and safety data for each subject in the trial required before an approval.

Source: GBI (


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