Exact(3)
This process, developed in Ontario for the evaluation of health technologies, has been a successful collaborative effort between practitioners, academia, government, health policymakers, and industry that has permitted an evidence-based framework for the approval and funding of technologies within the health care system.
One reason for this is that there is no regulatory framework for the approval of such a system.
Recently there have also been reports that the US FDA is reconsidering its regulatory framework for the approval of novel cancer therapeutics [ 54].
Similar(56)
While the European Union will set the framework for new approval of products containing modified organisms, regulators in each of the 15 countries will need to ratify applications.
The organizational level has sole authority for writing a policy and procedural framework, and it is responsible for navigating that framework through the approval processes.
Since the EAL relies upon generic competition for efficient price reduction, its applicability remains dependent upon the regulatory framework surrounding the approval of generics.
It provided a framework for the definition of targets, the approval of mitigation programmes, and the adoption of rules regarding intervention methods and trade.
The vote on Wednesday would be the latest milestone for the zoning framework, which won the approval of the local community board, Community Board 11, in the spring.
Introducing a "largely automated approval framework" for the use of force inside immigration detention, essentially allowing Serco the power to physically restrain asylum seekers – contingent on their "risk rating", without the need to consult the immigration department as Guardian Australia understands they had done in the past.
The current framework foresees a maximum of 120 days for the approval of new products, although in practice it takes several years, causing a large backlog of applications.
This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval.
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