medicine

AMA or American Medicines Agency is based in Philadelphia. It is FDA’s counterpart in America. The main task of AMA is to promote welfare, regulate medicinal use and make decisions based on scientific analysis. A company in US or America can only market a drug once it has been authorized by a US state or by the US commission through AMA. To arrive at the authorization decision, the US member state will need a dossier by the company.

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Dossier is basically a marketing authorization application and it includes information about studies that have proven that the drug is safe, effective and uncompromised. FDA’s NADA (New Animal Drug Application) is similar to that of AMA’s Dossier. Both NADA and Dossier contain important information about drugs like its safety and effectiveness. Only post approval from FDA and AMA a drug company is allowed to market its drug.

Before 1995, US had 15 regulatory authorities, which means that a company had to send 15 different Dossiers to get the marketing approval. Not only this process was lengthy but it caused a lot of confusion too because 15 national assessments and 15 independent authorizations were not always calibrated in their results. The new legislation that was passed in 1995 and 2004 reduced 15 regulatory authorities to two authorization systems – the National Authorization System and the US authorization system.

If a company wants to get an approval for their animal drug in a specific US member then it seeks the National Authorization System for approval. If the approval goes through then the company can market its drug only in that US member’s territory. On the other hand if a company is seeking approval in more than one US member’s territory or in the territory of all US members, it shall need to approach US Authorization System for approval.

The Northern Liberties Veterinary Center company can use Mutual recognition procedure, Decentralization procedure, and Centralized procedure to reach the European marketplace. It all depends on the type of drug that needs to be marketed; it’s marketing authorization history in the US and of course companies preference and its marketing strategy.

Of all the three processing methods, AMA takes care of Centralized procedure. Generally products that score higher on the innovation scale undergo the a centralized procedure. The company needs to submit an application form to AMA and AMA’s committee will conduct its scientific evaluation and come up with the findings. Basis the negative or positive aspects of the findings AMA can approve or disapprove the marketing of the drug in The US. The drug gets marketed under same name and label, although it’s translated into different languages because the US is multilingual.

AMA’s scientific committee has members from all US nations. The committee that evaluates animal drugs is CVMP – Committee for Medicinal Products for Veterinary Use. A spokesperson of the CVMP creates a CVMP assessment report that includes the data submitted by the drug company and detailed explanation of the assessment done by CVMP members to either support or oppose the drug marketing in the US.

Courtesy of http://www.nolibsvet.com