Followers | 45 |
Posts | 7008 |
Boards Moderated | 0 |
Alias Born | 02/24/2004 |
Thursday, November 09, 2017 8:14:03 AM
https://pharmaphorum.com/news/china-accept-overseas-clinical-trial-data/
China to accept overseas clinical trial data
October 9, 2017
The Chinese government has announced plans to accept data from clinical trials carried out overseas, in order to speed up approvals.
Reuters reported that the move was announced by the Chinese cabinet late on Sunday. It is a development that will be welcomed by international pharma companies, as medicines’ approvals are frequently held up because of stringent clinical trial data requirements.
Firms looking to launch drugs in China also face competition from the country’s homegrown pharma companies, and a tough government-controlled pricing environment.
The draft proposals state that the clinical trial data from overseas centres can be used for filings with its CFDA regulator as long as trial centres comply with Chinese drug and medical device registration requirements.
Firms looking to register drugs or medical devices for the first time will need to provide clinical trial data related to genetic differences in the Chinese population.
China is trying to shift away from use of generics and towards more innovative medicines and medical equipment.
The country’s State Council added the changes would make the country’s industry more competitive and help meet the clinical needs of its nearly 1.4 billion people.
China is becoming increasingly important to pharma companies because of the size of its population, prevalence of certain diseases, and its developing healthcare sector.
Cancer biotech BeyondSpring hopes to do the bulk of R&D for its new lung cancer drug plinabulin in China, a strategy that will cut development costs because of its links with hospitals and regulators.
Other companies have used similar strategies – Boehringer Ingelheim’s lung cancer drug Giotrif was approved by the FDA in trials where 72% of patients in a pivotal phase 3 trial were from China.
International pharma are also interested in developing diabetes drugs in China – AstraZeneca and Novo Nordisk are among the companies that are targeting the market, where around 150 million people are predicted to develop type 2 diabetes by 2040.
Novo Nordisk is hoping to gain a foothold with GLP-1 class diabetes drugs such as Victoza (liraglutide) and its developmental successor semaglutide.
And AstraZeneca late last month said it plans filings of its Bevespi Aerosphere COPD drug in China, where older drugs such as salmeterol and formoterol are commonly used to manage COPD symptoms.
Recent VCEL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:05:30 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/13/2024 08:13:39 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/12/2024 08:18:41 PM
- Vericel to Present at the Truist Securities MedTech Conference on Tuesday, June 18, 2024 • GlobeNewswire Inc. • 06/11/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/05/2024 08:05:33 PM
- Vericel to Present at the Leerink Partners Healthcare Crossroads Conference on Wednesday, May 29, 2024 • GlobeNewswire Inc. • 05/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 08:07:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 08:05:26 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/20/2024 04:15:48 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 08:05:50 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/16/2024 02:43:20 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/15/2024 05:10:15 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/08/2024 12:59:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 12:10:26 PM
- Vericel Reports First Quarter 2024 Financial Results and Raises Full-Year 2024 Financial Guidance • GlobeNewswire Inc. • 05/08/2024 11:55:00 AM
- Vericel to Report First-Quarter 2024 Financial Results on May 8, 2024 • GlobeNewswire Inc. • 04/24/2024 12:30:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/11/2024 08:15:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/11/2024 08:08:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/11/2024 08:07:02 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/08/2024 10:12:22 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/07/2024 08:35:28 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 02:04:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 01:04:33 PM
- Vericel Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Full-Year 2024 Financial Guidance • GlobeNewswire Inc. • 02/29/2024 12:55:00 PM
- Vericel to Present at the TD Cowen 44th Annual Health Care Conference on Tuesday, March 5, 2024 • GlobeNewswire Inc. • 02/27/2024 01:30:00 PM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM