Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

China Generic Drug Registrations Nose Dive

This article was originally published in PharmAsia News

Executive Summary

According to recent China State FDA figures, since the revised drug registration rule took effect last October, applications for generic drug registrations have nose dived while applications for new drugs have grown. During this one-year period, China has accepted applications of 553 new drugs, 155 formulation changes, 825 generic drugs, 502 imported drugs and 225 biological products. The generics figure contrasts sharply with the over 8,000 approved in 2005. SFDA officials think the trend indicates that new policies have held in check applications based on copying or modifying drugs with low R&D technology. The agency will publicize at the end of this year new drug applications approved since last October. (Click here for more - Chinese Language)

You may also be interested in...



Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments

Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

Merck & Co. Buys Out OncoImmune For Phase III COVID-19 Therapy

Deal snapshot: For $425m up front, the pharma obtains a Phase III recombination fusion protein that shows ability to improve hospitalized patients’ clinical status and reduce risk of death.

US COVID-19 Fraud: Latest Chloride Dioxide Products Linked To Claims Are Oral Rinses

Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.

UsernamePublicRestriction

Register

OM006550

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel