My staff burst into my office, “Ms. Chang, the CFDA reviewer called and wants this information right away!”
I get such “notifications” often nowadays, especially for those submissions that have been in review and have had their supplemental documents submitted already. The reviewer is asking for additional information and is requesting a response in a very short time frame – within a couple of days, or a week at the longest. Typically such calls prompt a rush of activities and sounding the alarm from my office in Beijing all the way to our clients in the U.S. or other countries. How we react and manage such requests and mobilize our support at the client side ultimately tests the resolve and tenacity of the Whitney team and our prospective clients.
Under the new CFDA regulations of 2014, reviewers for submissions have only one round of written questions after their first review. Due to the rule changes, the opportunity to meet with the reviewer to go through their questions and answers has been greatly limited. We are allowed two face-to-face meetings with the reviewer, and only with pre scheduling. Even if we have submitted the documents as per our discussions, reviewers can ask additional questions or raise new topics during their second round of review. Since no more written notification is permitted, the reviewer can opt to call the submitter and ask for additional information to be provided ASAP because he/she is now under the clock to push the submission out, and mark it as either approved or rejected.
The recent requests seem to be mainly about documents regarding the product’s life, the product packaging, and information on material. Reviewers may ask for design input and output documents, validation and verification reports as well as detailed COAs for materials. For legacy products, these documents may not exist or might be buried in the bottom of file drawers. But seeing the current trend of reviews, we want to alert all companies to get these “ancient” documents ready for submission and review. Being without these documents could mean rejection of submissions, the cost of which is not just the time (1.5 years to 2 years) but the money spent on testing and submission fees to CFDA. Surely CFDA has only one round of Q&A by regulation, but we should always be prepared for the second round, which is more demanding and time sensitive.
I hope companies, especially my clients, are ready for a call or email with the title “URGENT – CFDA questions” and respond as quickly as if our lives depend on it.