Advent Pharmaceuticals (AP) can coordinate and assist your company in accomplishing the three main steps required to get a new drug tested with the goal of approval by the SFDA in China. In its simplest form, the three main steps include:
1. Filing of your applications for approvals for clinical studies (either clinical trials or bio-efficacy studies). In the best case scenario, this process will usually take between 10 - 12 months in order to obtain approvals for clinical studies.
2. Step 2 involves conducting the clinical studies required for your drug/s which will either be clinical trails for new drugs or bio-efficacy studies for drugs that have come off patent in the US. Clinical trials typically take about 12-18 months and bio-efficacy testing typically takes about 3-6 months.
3. The final steps are taken if the clinical trials have favorable results and involve filing the applications for final approval with the SFDA. Once this process has begun, it usually takes 12-18 months to obtain the final approval of your drug/s in China.