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Jan 31, 2017

New FDA Guidance on Biosimilars
The US FDA published new draft guidance on “Considerations in Demonstrating Interchangeability With a Reference Product”

The guidance provides an overview of important scientific considerations in demonstrating interchangeability and is intended to assist applicants in demonstrating that a proposed therapeutic protein product (e.g., monoclonal antibodies) is interchangeable with a reference product under section 351(k) of the PHS Act. This guidance document discusses a number of factors such as type of data needed to support interchangeability, considerations for proper study design, and the use of already licensed reference products in these studies.

The FDA also issued a very good article discussing this draft guidance under a forum titled “From Our Prospective”.

Read the pdfRead more online

ICH Reflection on “GCP Renovation”
Modernization of ICH E8 and Subsequent Renovation of ICH E6

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).

The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. The underlying principles of human subject protection and data quality would remain. ICH’s decision to invite stakeholder comment on the proposed renovations at this early stage, ahead of guideline development efforts, recognizes the considerable stake and relevant expertise in the research community beyond ICH.

Stakeholders are invited to submit any comments to All comments should be submitted before the closing date for public comment, which is March 11, 2017

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CFDA on Medical Devices
CFDA releases results of first medical device quality review of 2017

In a drive to reinforce supervision on medical device quality and secure product safety and efficiency, the China Food and Drug Administration (CFDA) conducted its first random quality inspections in relation to 81 medical devices of 5 different varieties. One domestic-foreign joint venture, Hangzhou Huawei Medical Appliance Co., Ltd, is implicated.

Alongside the report, the CFDA urges local food and drug administration bureaus to investigate manufacturers and resolve matters in relation to products that failed the review. For full details, please refer to the source addendum.

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CFDA refreshes general Principles for Clinical Trials
CFDA released a set of general guiding principles for carrying out clinical trials in China

CFDA released a set of general guiding principles for carrying out clinical trials in China, aiming to provide applicants and researchers with the technical support to formulate integrated research and development (R&D) strategies and carry out individual clinical trials. Principles will also apply to already approved drugs being put into studies for new indications. The guidelines are described as generally applicable to chemical drugs and therapeutic biologics, and took immediate effect from date of publication.

General principles are set out according to the clinical study phases I to IV, addressing the various considerations according to pre-clinical, clinical pharmacological studies, exploratory clinical trials, confirmatory clinical trials, and post-marketing studies. The focus is on explicitly setting down some basic principles, including protection of human subjects within clinical trial protocols, control group selection, randomization and blinding principles, and other general methodological considerations for clinical research and development programs. Notably, there is also consideration for the impact of pharmacogenomics data on clinical studies, including patient and endpoint selection to most effectively demonstrate proof of concept. Please refer to the reference source for full details.

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Conditional marketing authorizations give patients access to important new medicines earlier
EMA publishes report with data collected between 2006 and June 2016

Conditional marketing authorization (CMA) can speed up access to medicines for patients with unmet medical needs. Since 2006, a total of 30 medicines have received a conditional marketing authorization. Medicines that were granted a CMA target seriously debilitating or life-threatening conditions such as HIV infection, breast cancer, and severe epilepsy in infants or multi-drug resistant tuberculosis. 14 were orphan medicines, providing patients suffering from rare diseases with new therapeutic options. These are some of the findings of a report by the European Medicines Agency (EMA) to mark ten years of experience with CMA.


The report shows that it took an average of four years to generate the additional data needed and to convert a CMA into a full marketing authorization. This means that patients with life threatening or seriously debilitating conditions can access promising medicines earlier.

The report also characterizes the data on which CMAs have been granted and the additional data generated through specific obligations. This information could be of interest for those developing medicinal products, as well as patients, pricing and reimbursement bodies and other stakeholders.

The report also identifies a number of possible areas for improvement. These include:

  • Prospective planning of CMAs and early dialogue with EMA to support the generation of high-quality data, timely discussion of additional post-authorization studies and their feasibility, and better data generation for completion of specific obligations;
  • Engaging other stakeholders involved in bringing a medicine to patients, in particular Health Technology Assessment bodies, to facilitate the generation of all data needed for decision-making through one development program.

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