beeldscherm schreef op 23 januari 2018 10:47:
Ook weer goed nieuws voor Pharming ,
China's fda gaat hervormen,
Dr Huang says: "I would summarize the importance of the reforms in three points."
"Number one, they allow for drug approval based on the trend of clinical benefit for patients, similar to the conditional approval seen in the USA. This means patients can get access to drugs much more quickly. We could potentially shorten the approval time by a year or two."
"Number two, the Chinese government is following the USA, EU and Japan, which can offer an up to five-year patent extension. This is very important for the industry, because if you can protect peak sales for another five years, there will be a lot more commercial value and then the company can invest more, so it's a beneficial cycle."
"Number three, it allows companies to use foreign data to support approval. In the old days there could be a five year or even ten year delay between approval in the USA and in China, because of the rule that you have to use Chinese patients to show safety and efficacy."
www.thepharmaletter.com/article/sweep...zou de stijging van afgelopen dagen hiermee verband houden....kan.