New Product Authorizations
Pharmaceuticals and other medicinal products need to be prior authorized by the regulatory authorities of the market/region they want to be sold in. Each market/region has a different framework and distinct guidelines for the review and assessment of pharmaceuticals. Each framework is unique therefore it is difficult for regulatory departments and organizations to implement authorization requirements and procedures without any errors. As a result, the timeline for the processes involved in evaluating a new product is extended. Additionally, requirements imposed by individual countries/regions, and the many guidelines and regulations from global organizations such as ICH and WHO can make the processes lengthier. Thus, the regulatory requirements and procedures for marketing authorizations of new products in various countries is quite diverse. Understanding these different regulations, developing a plan that adheres to the guidelines set by global authorities such as ICH and WHO makes it an exhaustive, complex process.