Strategic Drug Development in China and Surrounding Countries

Toward Optimum Benefit‐Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles

“…However, this review only focused on Japanese oncology drug approvals, and while the data suggest that the lag, although not eliminated, has considerably decreased in recent years, the delays in approval in certain Asian countries (e.g., China) owing to specific local requirements among other factors remain a challenge. For example, regulations in China specify local data from 100 patients pairs (active:reference) for small molecules and 300 patients/arm for biologics as being required to support registration, although the epidemiology of the disease may impact the specific requirements for a given development program …”

China's legal framework for pharmaceutical products: challenges and opportunities for EU companies

“…Conversely, in the case of imported drugs with a CPP, the imported drug application approach has a high probability of success, since the drug has already been approved abroad and its entire dossier can be submitted to the CFDA. Furthermore, "the new drug has been used in a fairly big study population overseas and had passed the high-risk stage of the early years" [Lu et al, (2015), p.517]. Moreover, "the imported drug registration study can be a miniature of the Pivotal Phase III trials and simply mimic the pivotal Phase III trials conducted overseas with a limited scope only in China.…”

“…Moreover, "the imported drug registration study can be a miniature of the Pivotal Phase III trials and simply mimic the pivotal Phase III trials conducted overseas with a limited scope only in China. Therefore, the investment is relatively small" [Lu et al, (2015), p.517].…”

“…More specifically, in the case of an imported drug application supported by MRCT data, "since this path allows the clinical programme to start earlier and before the overseas market approval, submission of the NDA to the CFDA for approval could take place right after the overseas approval. An estimated timeframe reduction in China is roughly 1.5 years" [Lu et al, (2015), p.517].…”

“…Using this method, they can catch up with the western world global development speed. The success of this path could give global companies very early entry to the Chinese market compared to the traditional import drug pathway or the aforementioned IMCT pathways being implemented by multinational pharmaceutical companies without local manufacturing capabilities" [Lu et al, (2015), p.517].…”