Safeguards for Accelerated Market Authorization of Vaccines in Europe

2021 ◽  
Author(s):  
Suzan Slijpen ◽  
Mauritz Kop
Keyword(s):  
Market Authorization

scholarly journals The EU Falsified Medicines Directive: Key Implications for Dispensers

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000024 ◽  
Author(s):  
Bernard D. Naughton
Keyword(s):  
Pharmaceutical Companies ◽  
Two Dimensional ◽  
European Directive ◽  
2D Barcode ◽  
Market Authorization ◽  
Falsified Medicines ◽  
The Impact ◽  
The Eu

The EU Falsified Medicines Directive (FMD) mandates the serialisation of prescription-only medicines using a two-dimensional (2D) barcode by pharmaceutical companies and the systematic verification of this 2D barcode in pharmacies. This European directive has ramifications for many stakeholders, including market authorization holders, wholesalers, parallel importers, and dispensers. Focusing primarily on the impact on UK dispensers, the following questions are addressed in this article: Where should the affected medicines be scanned? and who will pay for the incoming changes to practice? The role of the EU FMD in terms of drug recalls, the preparation required for EU FMD compliance, and the potential for added healthcare value are also discussed. Dispensers must prepare for the February 2019 EU FMD deadline date by choosing a point within their dispensing processes to scan medicines. Dispensers must also budget appropriately for the incoming costs associated with new hardware and processes.

scholarly journals Regulatory aspects for Biologic Product licensing in Australia

2019 ◽  
Vol 7 (2) ◽  
pp. 1-6
Author(s):  
Sanjeev Kumar Maurya ◽  
Vikesh Kumar Shukla ◽  
Sunny Kumar Maurya ◽  
Prachi Kaushik
Keyword(s):  
Human Cells ◽  
Human Tissues ◽  
Animal Cells ◽  
Regulatory Requirements ◽  
Live Animal ◽  
Regulatory Aspects ◽  
Physiological Processes ◽  
Market Authorization ◽  
Regulatory Guidelines ◽  
Biologic Product

The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). Explains the Australian regulatory requirements for supplying of Biologicals Explains what is required for the market authorization as per TGA especially for Biologicals.

scholarly journals Regulatory challenges of innovation in food and agriculture market authorization requirements for new foods

2012 ◽  
Vol 6 (1-2) ◽  
pp. 137-142 ◽  
Author(s):  
Bernd Van der Meulen ◽  
Anna Szajkowska
Keyword(s):  
Food Safety ◽  
Best Practices ◽  
Agricultural Products ◽  
Prior Authorization ◽  
Regulatory Authorities ◽  
Food And Agriculture ◽  
Market Authorization ◽  
Pros And Cons ◽  
Fair Balance ◽  
Regulatory Challenges

Regulatory authorities face the challenge to strike a fair balance between the interests of consumers to ensure the safety of innovative foods and agricultural products and the interest of innovative businesses.Worldwide prior authorization schemes are applied. This contribution explores characteristics, pros and cons of such schemes. It identifies concerns but also best practices that may contribute to improving food safety without unduly hampering innovation.

scholarly journals Conditional approval of cancer drugs in Canada: accountability and impact on public funding

2019 ◽  
Vol 26 (1) ◽  
Author(s):  
S. K. Andersen ◽  
N. Penner ◽  
A. Chambers ◽  
M. E. Trudeau ◽  
K. K.W. Chan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Outcome Measures ◽  
Preliminary Data ◽  
Public Funding ◽  
Surrogate Endpoint ◽  
Cancer Drugs ◽  
Market Authorization ◽  
Oncology Review ◽  
Health Canada ◽  
Positive Recommendation

Background We examined how conditional market approval of cancer pharmaceuticals by Health Canada (hc) affects public funding recommendations by the pan-Canadian Oncology Review (pcodr). We were also interested to see how often hc conditions are enforced.Methods Health Canada and pcodr databases for 2010–2017 were analyzed for patterns in hc conditional authorization and post-authorization reviews of cancer drugs and for correlation with pcodr reimbursement recommendations.Results Between 2010 and 2017, pcodr reviewed 105 unique drug–indication pairings; 21% (n = 22) had conditional hc authorization. In all cases, conditional authorization was given on the basis of preliminary data in a surrogate endpoint and was contingent on further data showing benefit in more robust outcome measures (for example, overall survival). Of those 22 drugs, 36% did not have updated data, 36% had updated data that met hc conditions, and 27% had data that met some, but not all, conditions. During the period considered, hc never revoked conditional authorization for failure to meet conditions. None of the 22 drugs was given an unconditional positive recommendation for public reimbursement by pcodr. A conditional recommendation was given to 11 of the drugs (50%), and reimbursement was not recommended for 6 drugs (27%) because of insufficient evidence.Conclusions One fifth of the cancer drugs reviewed for public reimbursement in Canada were conditionally authorized by hc based on preliminary data. Conditional authorization was associated with a recommendation against public funding by pcodr. No drugs had their conditional market authorization revoked for failure to meet conditions, suggesting that a more robust hc reappraisal framework is needed.

scholarly journals Lessons Learned from the Clinical Development and Market Authorization of Glybera

2013 ◽  
Vol 24 (2) ◽  
pp. 55-64 ◽  
Author(s):  
Laura M. Bryant ◽  
Devin M. Christopher ◽  
April R. Giles ◽  
Christian Hinderer ◽  
Jesse L. Rodriguez ◽  
...  
Keyword(s):  
Clinical Development ◽  
Lessons Learned ◽  
Market Authorization

scholarly journals PHP13 MARKET AUTHORIZATION (MA) AND REIMBURSEMENT: ANALYSIS OF THE POST-MA TIMELINES AND THE ACCESS TO NEW MEDICINES IN BELGIUM

2008 ◽  
Vol 11 (6) ◽  
pp. A366
Author(s):  
F Arickx ◽  
M Pierlet ◽  
E Soete ◽  
E VanHaeren ◽  
P Verplanken ◽  
...  
Keyword(s):  
Market Authorization

scholarly journals Navigating Market Authorization: The Path Holoclar Took to Become the First Stem Cell Product Approved in the European Union

2017 ◽  
Vol 7 (1) ◽  
pp. 146-154 ◽  
Author(s):  
Graziella Pellegrini ◽  
Diego Ardigò ◽  
Giovanni Milazzo ◽  
Giorgio Iotti ◽  
Paolo Guatelli ◽  
...  
Keyword(s):  
European Union ◽  
Stem Cell ◽  
The European Union ◽  
Cell Product ◽  
Market Authorization ◽  
Stem Cell Product
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