• The coronavirus (COVID-19) is having global public health implications and its economic impact cannot be underestimated. The full extent will not be known until many months, or even years, down the road. On the regulatory side, we are often asked by companies who conduct business in China how this will impact the ability to seek new product clearances and whether pending dossiers will be delayed.
  • The virus hit China at a time when the country was celebrating the Chinese New Year, so most government agencies responsible for reviewing various food, drug and cosmetic dossiers were closed for business. Since that time, there have been over 80,000 cases in China, mostly in Wuhan, the capital city of Hubei Province. In Shanghai, where Keller and Heckman has its Asian operations, the city has seen a total of 338 people diagnosed with the virus.
  • The applications for various products in China have been impacted by the outbreak, but the government is doing the best it can under the circumstances to bring things back to normal. Government employees in various agencies are reporting back to work, albeit on a limited and restricted basis. By way of a few examples, the Center for Drug Evaluation (CDE) continues to process submissions of Drug Master Files (DMFs). Applications for non-special purpose cosmetic products can be submitted to provincial-level market regulation agencies in person or preferably by mail. For petitions handled by the National Health Commission (NHC) and Center for Food Safety and Risk Assessment (CFSA), including food additives, new food ingredients and food-related products, dossiers are accepted, but the corresponding expert panel review meetings may be delayed, given that “group gathering” events are not currently allowed in Beijing.
  • The team in Keller and Heckman’s Shanghai office has returned to work remotely since early February. Thus, they are ready to serve our clients in matters related to China and APAC regions.