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Regulatory Compliance/FDA but there is variation within Asia. While Australia tends to follow the global guidelines, South Korea, Vietnam, India, China, and Russia have their own special requirements, like the need for local patient data." In terms of the submission format, countries are beginning to move closer to the international submission template (eCTD — electronic common technical document). Similarly, the trend is toward more harmonization in legal frameworks among the countries. For example, China's regulatory processes are evolving, creating a framework that is more closely aligned to the U.S. and European legislation, and in both South Korea and China, the regulatory agency has been raised to the ministry level. UNDERSTANDING THE CHALLENGE Even as the guidelines are becoming better harmonized, some very specific local requirements are becoming significant enough to shape the entire worldwide strategy. These can be as simple as the need for translations, or as complex as the structure of the entire clinical trials. "The reality is, emerging markets are more complex than they seem on the surface. There are thousands of local manufacturers and a staggering number of approved products, all controlled by relatively small regulatory agencies. China is a key example of this," says Scheeren. Some countries will require translations of the summary or the whole file, whereas others may accept abbreviated files if the product has been approved elsewhere. "For marketing authorization submissions, some countries require very specific local clinical trials. For example, China has minimum requirements of 100 pairs of patients in small molecule trials and 300 pairs in biologics. This is particularly challenging for companies developing drugs for small populations and orphan indications where the global development plan only intended enrollment of a few hundred patients," says Scheeren. These differences can have a significant impact on time lines, thus incurring delays. For example, if separate trials are needed, this could slow registration by two to four years. The time taken for approval of individual steps in the process may also differ. "The assessment period for clinical trial applications (CTAs) in China can be long, and may require the drug developer to conduct a national trial, making it a challenge to integrate it into a global clinical program," says Scheeren. "Other emerging markets, such as South Korea, have faster time lines and therefore are easier to integrate." Most emerging markets do not have electronic filing systems for CTAs and NDAs (new drug applications), and so the need to submit December 2013 LifeScienceLeader.com 41