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Feb 1, 2019

FDA update on eCTD submissions
Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA) has specified the electronic format for submitting submission types to the Agency, such content must be submitted electronically and in the format specified by FDA. This guidance and the technical specification documents it incorporates by reference describe how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act.

This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

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Two new FDA REMS guidelines issued
Planning and Reporting Guideline as well as Knowledge related Survey Guideline available

The first document provides guidance to industry on the assessment of risk evaluation and mitigation strategies (REMS) for prescription drug products, including biological products. This guidance describes how to develop a REMS Assessment Plan, specifically, how the REMS program goals, objectives and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the program is meeting its risk mitigation goals. The guidance also discusses considerations for assessing the impact of REMS on patient access to the drug and its burden to the healthcare delivery system. Finally, this guidance provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.

The second guidance provides recommendations to industry on conducting risk evaluation and mitigation strategies (REMS) assessment surveys, used to evaluate respondent knowledge of REMS-related information. This guidance discusses general principles and recommendations related to conducting REMS assessment knowledge surveys, including study design, survey instrument development, survey data collection and processing, and data analysis.

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Chinese National Health Committee released new requirements for Clinical Trials
China to require the clinical trial centers to establish an independent clinical trial department and to reform the Ethics Committees (EC)

The reform has major changes in the following according to Release No 03, 2019:

1) Clinical trial centers (hospitals where clinical studies are conducted) should establish an independent central office to oversee all the clinical trials taking place at that particular hospital.

2) For phase I trials, centers should use the “Clinical Study Volunteer Database System” to manage the healthy volunteers and keep the information up-to-date. It is also encouraged using the system in phase II – IV clinical trials.

3) Every department (i.e., clinical, lab, administration, and logistic, etc.) involved in a clinical trial shall assign at least two people to engage in the related work.

4) It is also encouraged implementing an electronic clinical trial data management system.

5) All clinical trial staff must be trained in GCP and obtain a certificate prior to participating in any clinical trial. Re-certification must not exceed five years.

6) The Ethics Committee (EC) must review any application within 20 business days. Multi-center clinical trials should follow instructions from the lead center and only need to review the feasibility and provide a written reply or approval (if approved) within 10 business days after receiving the application.

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New draft AE report form in China
The Drug Evaluation Center of the NMPA issued the draft for public comment

The form specifies the requirements and gives instructions on the accountability and scope of MAH’s AE reporting (including products that have been approved). The form requires patient information, medication (including suspected medication and concomitant medication), detailed description of the AE, laboratory result, if applicable, information on pregnancy (if applicable), sources of the report, and contact info of the reporting person.

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EMA Relocation Update
EMA aims at being operational in Amsterdam from 30 March 2019 onwards

With Brexit looming, EMA takes every precaution to manage the challenge of moving to Amsterdam and to cope with an approximate loss in personnel of about 25%.

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EMA revises Guideline on Evaluation of Antibiotics
Revised guideline aims to strengthen global approach to development of new antibacterial medicines

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation. Stakeholders can send their comments by 31 July 2019 to using the template provided.

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