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Nov 1, 2017

 
Widler & Schiemann open China Office
Business license obtained, first employee hired

On October 23rd, we hired our first employee at our office in Shanghai, China. Widler & Schiemann decided to open a branch office in China to serve our clients even better with a team that is local. The Shanghai office will focus on China first, but long term be responsible for projects in all countries in the APAC region. The office is currently managed by Dr. Peter Schiemann, managing partner at Widler & Schiemann Ltd., who works in China since early 2016. Later this year we plan to hire a managing director for our branch office to run operations as the accountable person to our clients.





Update on USFDA Draft Guidance on REMS
Update on format and content of a REMS document – Revision of the 2009 Guidance

This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product.

A REMS document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS. This guidance provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer, more informative, and supports submission of a REMS document in Structured Product Labeling (SPL) format. FDA does not expect applicants of an approved product subject to a REMS to submit a proposed REMS modification solely to convert their REMS document to the new format. Changing the REMS document to the new format should be done in conjunction with other REMS modifications.

This guidance provides an overview of the types of information that should be included in a REMS document. Additional and more detailed information is provided in the template appended to this guidance, which is also available on FDA’s Web site.

This guidance and the appended template are intended to help ensure that REMS documents are clear, understandable to stakeholders, and to the extent possible, consistent in content and format.

Comments are invited during a 60 days period.

Read the pdf



New USFDA Draft Guidance on ANDA and 505(b)(2) Application
USFDA provides a guide for decision making whether to submit an ANDA or 505(b)(2)

This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. Many potential drug product developers are familiar with neither the different abbreviated approval pathways for drug products under the FD&C Act — the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively) — nor the types of data and information that are permitted to support approval under those pathways. In order to familiarize potential drug product developers with these abbreviated pathways, this guidance highlights criteria for submitting applications under the abbreviated approval pathways described in section 505(j) and 505(b)(2), identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under section 505(j) or pursuant to section 505(b)(2) of the FD&C Act, and provides direction to potential applicants on requesting assistance from FDA in making this determination.

Read the pdf



Updates on EMA Guideline on Good Pharmacovigilance Practice
Two of the updated Modules will become effective in November 2017

The EMA’s GVP Guideline consists of several modules, two coming into effect in November after a revision:

Module VI: Collection, Management and Submission of Reports of suspected Adverse Reactions to Medical Products (including Addendum I)

Module IX: Signal Management (including Addendum I)

Read more online



China now accepting Clinical Trial Data from other Countries
CFDA issued a new guideline announcing that for submissions clinical trial data from other countries will be accepted

A new guideline was issued by the General Office of the Communist Party of China Central Committee and the General Office of the State Council early October. According to a post by the State Council, the guideline aims to promote “the adjustment of industrial structure and technological innovation in the sector of drugs and medical devices, improving industrial competitiveness, and meeting the public’s clinical needs.”

Read more online CFDA announcement in Chinese



China will allow private hospitals and other health related institutions
In his speech at the 19th National Congress of the CPC, President Xi Jinping emphasized the focus on “Healthy China”

"A healthy population is a key mark of a prosperous nation and a strong country. We will improve the national health policy, and ensure the delivery of comprehensive lifecycle health services for our people. We will deepen reform of the medicine and healthcare system, establish distinctively Chinese systems for providing basic healthcare, medical insurance, and quality and efficient healthcare services, and develop a sound modern hospital management system.

We will improve community-level healthcare services, and strengthen the ranks of general practitioners. We will put an end to the practices of hospitals funding their operations with profits from overpriced drugs, and improve the system for medicine supply.

We will, with emphasis on prevention, carry out extensive patriotic health campaigns, promote healthy and positive lifestyles, and prevent and control major diseases. We will initiate a food safety strategy to ensure that people have peace of mind about what they’re putting on their plates. We will support both traditional Chinese medicine and Western medicine, and ensure the preservation and development of traditional Chinese medicine. We will support the development of private hospitals and health-related industries.

We will work to ensure that our childbirth policy meshes with related economic and social policies, and carry out research on the population development strategy. As we respond proactively to population aging, we will adopt policies and foster a social environment in which senior citizens are respected, cared for, and live happily in their late years. We will provide integrated elderly care and medical services, and accelerate the development of old-age programs and industries. "



 

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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - info@wsqms.com - http://www.wsqms.com