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The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees. Read More
The Supreme Court of Canada struck down the “promise doctrine” used in the evaluation of a patent’s validity — a victory for the pharmaceutical industry, which said its use has led to the cancellation of over two dozen drug patents in the country over the past ten years. Read More
The Supreme Court’s ruling this week on a patent dispute over printer toner cartridges could have wider effects on the pharmaceutical industry, international sales and product reimportation. Read More
China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Read More
The European Medicine Agency’s revised guideline on the chemistry of active substances — outlining the information companies must provide the agency about the chemical entities used in a drug product — goes into effect this week. Read More