Author name: development

Pharmaceutical companies have faced delays in receiving a response to their Suitability Petitions by the United States Food and Drugs Administration (US FDA). This has been a problem as delay in responses have led to the delay of Abbreviated New Drug Applications (ANDA) entering the market. The US FDA has committed to proactively reviewing the

The International Recognition Procedure (IRP), initiated by the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexit, establishes an international recognition route for medicines with pre-existing approvals from Canada, Australia, the EU, Japan, Switzerland, and the US. Operating alongside existing national procedures, the IRP is a crucial pathway for introducing innovative medications to UK patients while

The importance of aligning pharmaceutical regulations in the development process has become increasingly evident particularly in the current era that has characterized by global interconnectedness. Indeed, the need for harmonizing frameworks that govern medicine regulation and subsequently supporting bilateral trade has increasingly become imperative. As various pharmaceutical markets go beyond borders, disparities in their respective