Data Exclusivity Hk

India the controller general of patents designs and trade marks is the authority that issues patents in india.

Data exclusivity hk. The critical paths and end points for key initiatives were also shared. This period of data protection prevents a competitor from relying on the innovator s clinical data when seeking approval of a generic version of the same drug in front of the same regulatory agency. For the 2012 2014 the focus of our directions will be on enhancing drug accessibility drug safety communications and drug education.

India the controller general of patents designs and trade marks is the authority that issues patents in india. The hong kong association of the. Data protection laws and regulations 2020.

Test data exclusivity refers to protection of clinical trial data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug and prevention of generic drug manufacturers from relying on this data in their own applications. Yes there is an eight year data exclusivity period for the originator of pharmaceutical products registered in hong kong. More far reaching extension of patent term provisions to come.

Data exclusivity refers to a period of data protection of clinical test data that is provided by an innovator company to a regulatory agency to prove the safety and efficacy of a new drug. Data exclusivity refers to a period of protection for data provided by an innovator company to a regulatory agency to prove the safety and efficacy of a new pharmaceutical product. Iclg data protection laws and regulations covers common issues including relevant legislation and competent authorities territorial scope key principles individual rights registration formalities appointment of a data protection officer and of processors in 39 jurisdictions.

Data exclusivity prevents generic competitors from relying on the clinical data submitted by the original pharmaceutical manufacturer for a certain period of time. It provides a form of market exclusivity outside that provided by patent rights. Data exclusivity is the period of nonreliance and nondisclosure during which the preclinical and clinical data generated by the innovator company as part of their new drug application marketing authorization application also known as pharmaceutical registration data cannot be referenced in the regulatory filings of another company for the same drug substance.