Standards Used in Meeting Requirements for a Model Pre-Market Approval (PMA) of a Neural Guidance Conduit

2008 ◽  
pp. 182-182-15
Author(s):  
L Stover ◽  
A Hubel
Keyword(s):  
Market Approval

LONG TERM RIGIDITY AND STRONG ERECTIONS REPORTED BY PATIENTS IMPLANTED WITH THE COLOPLAST/MENTOR ALPHA 1 PENILE PROSTHESIS DURING FDA PRE MARKET APPROVAL STUDY

2008 ◽  
Vol 179 (4S) ◽  
pp. 406-407
Author(s):  
Joel M Kaufman ◽  
Chirpriya B Dhabuwala ◽  
Fernando D Borges ◽  
Bruce B Garber ◽  
David F Mobley ◽  
...  
Keyword(s):  
Penile Prosthesis ◽  
Market Approval

scholarly journals Ethical considerations in post-market-approval monitoring and regulation of vaccines

Vaccine ◽  
2014 ◽  
Vol 32 (52) ◽  
pp. 7171-7174 ◽  
Author(s):  
Alison Thompson ◽  
Ana Komparic ◽  
Maxwell J. Smith
Keyword(s):  
Ethical Considerations ◽  
Market Approval ◽  
Post Market

scholarly journals Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study

2020 ◽  
Author(s):  
Joel Lexchin
Keyword(s):  
Prescription Drugs ◽  
Development Time ◽  
Patent Application ◽  
Trade Agreement ◽  
The European Union ◽  
Market Approval ◽  
Trade Offs ◽  
Patent Term ◽  
Significant Difference ◽  
Patent Filing

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for prescription drugs by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and market approval). This study investigates overall development time in Canada for different groups of drugs approved between January 1, 2009 and December 31, 2018 and how many of these drugs are eligible for up to 2 years of patent term extension. Based on a list of patents and dates of market approval, the change in overall development time for all drugs was calculated along with whether there were differences in development time between different groups of drugs. Using Canadian patent filing dates, overall development time for all drugs went from a mean of 2240 days (95% CI: 1832, 2648) in 2009 to 4197 days (95% CI: 3728, 4665) in 2018 (analysis of variance [ANOVA], P<.0001). Using first global patent filing dates, overall development time went from a mean of 4481 days (95% CI: 3053, 5908) in 2009 to 6298 days (95% CI: 4839, 7756) in 2018 (ANOVA, P=.0118). There was a statistically significant difference in the overall development mean time between small molecule drugs (3553, 95% CI: 3361, 3746) and biologics (3903, 95% CI: 3595, 4212), (t test, P=.0487) when using Canadian patent filing dates but not when first global patent filing dates were used. There was no statistically significant change in overall development time among drugs that were substantial, moderate or little to none additional therapeutic value compared to existing drugs. Out of 238 drugs, 218 (91.6%) would have been eligible for patent term extension with 195 (80.7%) eligible for the full 2 years. Patent term extension does not appear to be justified based on changes in overall development time, except possibly in the case of biologics. There are also trade offs in terms of increased expenditures that need to be considered if patent terms are lengthened.

A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN

2014 ◽  
Vol 2 (2) ◽  
pp. 1-4 ◽  
Author(s):  
S.K.R Parasiya ◽  
V Balamuralidhara ◽  
Pramod T.M. Kumar ◽  
R Gujarati ◽  
A Shukla ◽  
...  
Keyword(s):  
New Drugs ◽  
Public Healthcare ◽  
Local Market ◽  
Ageing Population ◽  
Market Approval ◽  
Drug Registration ◽  
Drug Regulations ◽  
Economic Trends ◽  
Growth And Change ◽  
The Government

Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for instance, can be taken as an example. Taiwan has one of Asia's most highly-praised healthcare systems with excellent provision of healthcare and key health outcomes. Nevertheless, the government is facing new pressures for public healthcare reforms as result of a rapidly ageing population and rising healthcare costs. This paper provides an introductory overview of Taiwan’s sudden changes in its Drug regulations due to TFDA (The Taiwan Food and Drug Administration) establishment in 2010, TFDA of the Department of Health (DOH) made an advance announcement about the “amendment draft of the Provisions Governing the Registration and Market Approval of Drugs”, which amends a total of 40 Articles. Without impeding the quality, safety and therapeutic effect of Drugs, most of the amended Articles are about simplification of application procedures and loosening of regulations for Drug registration and market approval. Regulations loosened are imposed on new Drugs, Radioactive Drugs, Allergenic Drugs and Drugs for export that is intended to accelerate the process to sell new Drugs on the market and promote the export of domestically manufactured Drugs. As a result of these changes in regulations many pharmaceutical MNCs and local manufacturers explored their business in Taiwan due to quick approval of their NDAs and gained more flexibility in the local market. To support Taiwan's generic Drug industry, DOH has also decided to take measures to simplify and reduce the ANDA application time.

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