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Language in newly signed free trade agreements covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of lawmakers contends.
Australia’s Therapeutic Goods Administration (TGA) has released a discussion paper aimed at improving access to consumer medicines information (CMI) and product information (PI).
South Africa’s Medicines Control Council (MCC) recently implemented final guidance on the submission of post-registration amendments concerning medicines and changes to facilities, including change of manufacturer or holder of the certificate of registration.
Details on conducting clinical trials under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) are laid out in a new consultation paper released by the two countries’ current regulatory authorities.
Health Canada has issued draft guidance on the administration of the amended Patented Medicines (Notice of Compliance) Regulations, which went into effect in October 2006 (IPRM, October 2006).
The European Medicines Agency (EMEA) recently published draft guidance for industry on technical requirements for marketing authorization applications for human tissue-engineered products (hTEPs).
The UK National Health Service’s (NHS) drug price regulation scheme should be changed to a value-based system that focuses more on patients and improving benefits, according to an Office of Fair Trading (OFT) report.
The European Medicines Agency (EMEA) has released for comment draft guidance on acceptable limits of metal residues in drug substances and excipients (inert substances that aid in binding a pill or tablet).
The European Union (EU) and Japan have signed an agreement permitting the exchange of confidential information about the authorization and safety of medicines.
Generic drug firms operating in the European Union (EU) should work closely with state agencies to mitigate drug approval delays caused by bureaucratic overload, the European Generic medicines Association (EGA) said at an industry conference in February.