African Medicines Regulatory Harmonization

African Medicines Regulatory Harmonization

The programme is an African Union initiative that will help autorities from other countries to create and keep standarts in drug regulations which harmonise whole segment. Ndomondo-Sigonda as main organizator is ready to hold conference in Ethiopia to establish African Medicines Agency. There is huge urgency to regulate drug policies. People need to work together to unifie huge drug system across the continent.

As AMRH we need to harmonise our attitude to this new developed aphrodisiacs in our markets. Number of products called spanish fly is outstanding therefore is unified regulation necessary. As Worldbank states: “Improved medicines regulatory policy and harmonization efforts can lead to more competitive markets, economic growth, improved access to new medicines, better quality of pharmaceuticals in circulation and ultimately better health outcomes.”

First of all w would need to define if we regulate medicinal product or dietary supplement. Some of Spanish fly products could be coinsidered as medicines because of its ingredients. “Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis[1]

Definitely it is important to compare all products launch dates, ATC codes, names and defined daily dose (DDD). [2]

There are many new drugs today which starts to raise in popularity. First point of our conference would be new substances called spanish fly.

As Wikipedia itself stated “Spanish fly is an emerald-green beetle, Lytta vesicatoria, in the blister beetle family (Meloidae). It and other such species were used in preparations offered by traditional apothecaries, often referred to as Cantharides or Spanish fly. The insect is the source of the terpenoidcantharidin, a toxic blistering agent once used as an aphrodisiac.[3]

Because drug regulatory systems in most African countries are not well developed, we compared all Spanish Fly product in all five continents.[4]

References

[1] Medicines and Healthcare products Regulatory Authority. A guide to what is a medicinal product. MHRA Guidance Note No. 8. Revised November 2012. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/398998/A_guide_to_what_is_a_medicinal_product.pdf. Accessed 12 Oct 2014.

[2] WHO Collaborating Centre for Drug Statistics Methodology. Complete ATC/DDD Index 2008. http://www.whocc.no/atc_ddd_index/. Accessed 21 Apr 2013.

[3] https://en.wikipedia.org/wiki/Spanish_fly

[4] Isah AO, Pal SN, Olsson S, Dodoo A, Bencheikh RS. Specific features of medicines safety and pharmacovigilance in Africa. Ther Adv Drug Saf. 2012;3:25–34. doi: 10.1177/2042098611425695.

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