Concerns for group

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1365 views

What is seen as the major concerns for panelist with global harmonization?

Pharmaceutics
Medical Devices
Regulatory Requirements
COURTLAND IMEL
74 months ago

4 answers

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Globalization is still a difficult road with lots of obstacles and crossroads. Depending on the business we have to deal with a global approach might be a nightmare or business only approach. When you refer to pharmaceuticals one has the global support of ICH and many transnational agreements that ease your path. However you have to face sometimes severe local regulations that prevent foreign investment or protect the local companies. Some governments may also threat your IP reduce the prices.
Medical devices are less strict than medicines.However, all around the world there's an issue with prices and governments might force you to reduce price to authorize your participation in public offers.
Other products less regulated or safer might get global very quick.

Pedro AS
74 months ago
Not in the USA - Dr. David E. 63 months ago
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Pedro,
My main fear is the globalization of inspections, as ANVISA, which has had a strong reputation of bribery, is given the same level of authority as USFDA, MHRA, PICs, or Health Canada. With the recent change of device regulations in the EU, when will the rest of the countries catch up to Canada and EU. This globalization may also impact regulatory submissions. We already have eCTDs. US and Canada are getting closer each year. Issues ahead? International pharmacopeia, greater acceptance of regulatory submissions, and increased surveillance activities shared by all regulatory authorities. We also have countries that do not recognize drugs equally. Here in the US, we list actives as dietary supplements that are recognized as drugs in Russia, England, and Australia, and vice Versa.

In your cosmetic expertise, you see similar issues in colors.

Thanks,
courtland

COURTLAND IMEL
74 months ago
Interesting - Dr. David E. 63 months ago
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There are several areas of global harmonization along the biopharma value chain. Starting with TRIPS and the recent WHO push to harmonize IP, this is generally helpful to the innovative industry players to continue protecting their intellectual property. ICH in clinical development is also moving slowly toward harmonization which is generally positive for the innovative global players to avoid repeating studies, gaining access to clinical populations of statistical significance and mutually recognizing approvals between countries (EU and emerging countries recognzing approvals). Harmonization in PMS has also been beneficial to patients and for pharmacos to gain scale in detecting and reporting issues efficiently, but more remains to be done here with notification periods, data and report types. The areas of greatest need is harmonization of API and ingredient quality assurance in biopharma supply chains. Lack of standards here is threatening availability of safe medicine and the brand reputation of many international generic and ethical players. Finally harmonization of application and payment of medicines is the area of greatest risk for innovative ethical biopharma companies. This level of harmonization beyond country boarders is unlikely to occur - the practice of medicine (including definition and treatment of disease), consumer dosing and administration preferences and national health and defense policies are too varied today to provide the commonality and stability required to gain concensus among countries for pricing and practice harmonization to occur in a way that meaningfully changes the biopharma business in the short term. Of all markets, the the US is the one whose move toward harmonization of international pricing and practice is of greatest negative impact to the pharma industry.

Fred Brown
74 months ago
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For me harmonization is not seen as a pitfall but more as a good way of improvement from the health authorities to support their inspection wherever the inspection is taking place. by this way, Manufacturer would be able to focus not only on supporting audits from different authorities from exotic countries and Highly regulated countries. It is in fact already the case for a lot of them but some others are still reluctant to harmonize and are keen to maintain their audits.
By Harmonization, Manufacturer will be able to finally concentrate on good production instead concentrating on good audit reports.

Franck PAVAN
74 months ago
Thanks - Dr. David E. 63 months ago

Have some input?