What does RIAS stand for?

A Regulatory Impact Analysis Statement was also published.

The regulatory amendments impose a new requirement for import permits for all live bovine imports from the United States, the agency said in a regulatory impact analysis statement published with the finalized Health of Animals Regulations in the Feb.

In addition to the Exclusion Regulations, the government issued a Regulatory Impact Analysis Statement which delves into the rationale behind the regulations.

According to the Regulatory Impact Analysis Statement accompanying the amendments, the rationale behind lifting the prohibition on prevention claims for NHPs and OTCs is that prevention of a Schedule A disease will typically not require the intervention of a health practitioner, in contrast to the treatment or cure of a Schedule A disease.

Footnotes 1 Regulatory Impact Analysis Statement for the amendments to the Food and Drug Regulations 2 Regulatory Impact Analysis Statement for the PM(NOC) Regs amendments 3 In Canada an inventor has one year after taking a step which makes the invention available to the public within which to apply for a patent.

According to the Regulatory Impact Analysis Statement (RIAS) issued by the government to explain the proposed amendments, the purpose of these amendments is to restore the balance between the rights of patent holding drug manufacturers (innovators) and the generic drug manufacturers (generics), in order to ensure a balance between the two policy goals of effectively protecting pharmaceutical inventions (in order to stimulate research and development) and keeping the cost of medicines down.

According to the accompanying Regulatory Impact Analysis Statement (RIAS), the reference to patents with claims to dosage forms reflects the government's recognition that novel dosage forms can offer significant therapeutic advantages over drugs with conventional release characteristics.

The Regulatory Impact Analysis Statement (RIAS) recognizes that in actual practice the current provisions of the Food and Drug Regulations do not provide a period of data protection.