Two new Chinese pharmaceutical companies are added to the FDA import ban list: the first batch of pharmaceutical companies to be banned for violating gdufa

Source: HPC drug news and drug affairs July 15, 2016 FDA issued a new import ban (importalertා66-76) on July 13, 2016, imposing automatic seizure (dwpe) sanctions on two Chinese pharmaceutical enterprises and two Indian enterprises The listed companies include Jiangsu Zhongwei Pharmaceutical Co., Ltd., Wuxi Kaili Pharmaceutical Co., Ltd and two companies in India, Fleming laboratories Ltd and Sharon bio medicine limited The reason for the automatic seizure is that the self identifying data and the facility fees are not submitted as required by gdufa This is the first time that an enterprise has been sanctioned by dwpe issued by FDA for violating gdufa regulations Gdufa's definition of production facilities refers to enterprises or other entities that are engaged in API or preparation production and processing activities and located in a certain geographical location or location According to gdufa, Congress authorizes FDA to evaluate the cost of production facilities involved in approved or reviewed generic drugs If an enterprise participates in the review or approved generic drugs, or the production and processing of API contained in generic drugs, the owner of the production facility must submit the information about the production facility to FDA in accordance with 21u.s.c.section379j-42 (f), i.e self identification These self identification data can help FDA to estimate the annual cost of production facilities As long as it involves the production and processing activities of generic drugs or approved generic drugs in the declaration and related API, the owner of the production facility needs to pay the annual production facility cost The cost is calculated according to the geographical location of the production facilities, regardless of the number of production varieties If the same manufacturing enterprise produces generic drugs in different locations, it may pay one or more production facility fees according to its geographical location For details, please refer to self identification of generic drug facilities, sites, and organizations In general, each facility establishment identifier (Feis) has to pay an annual production facility fee, while the API and preparation manufacturers have to pay two different production facility fees respectively In 2014-2017, the annual production facility cost is required to be paid before October 1 or the first working day after that year In 2015, the production facility cost paid by the pharmaceutical manufacturers outside the United States is 262717 US dollars (2016: 258905 US dollars), and the production facility cost paid by the API manufacturers outside the United States is 56926 US dollars (2016: 56926 US dollars) $55867) However, it is not required to pay for production facilities that only produce pet drugs For enterprises that do not pay annual production facility fees, FDA will disclose their information in the gdufa production facility fee arrears list If the company fails to pay the fee within 20 days after receiving the FDA's reminder, the FDA will not accept the generic drug declaration submitted by the person in charge of the overdue fee or the organization associated with it According to the regulations of FFDCA, for the production facilities used in the production and processing activities of drugs or API, if the cost of the production facilities should be paid but not paid, or if the self identification materials are not submitted, the drugs produced are identified as fake products At the same time, the regulation stipulates that the counterfeit products may be prohibited from entering the U.S market All the production facilities listed in the import ban have received FDA warning letters (Jiangsu Zhongwei Pharmaceutical Co., Ltd and Wuxi Kaili Pharmaceutical Co., Ltd received warning letters in 2015; Fleming laboratories Ltd and Sharon bio medicine limited in 2014 and 2015 respectively Received a warning letter in, informing them that they have violated the laws and regulations, and that the products may be considered as fake products and are prohibited from entering the U.S market However, these enterprises did not make obvious efforts within the time required by these warning documents If the owner or importer of the production facility requests to remove the goods from the automatic detention list, he / she shall provide sufficient information to the FDA import operations (DIO, division of import operations) to prove that the owner of the production facility has solved the relevant violations, fully complies with the requirements for payment of fees and submission of self identification information stipulated by gdufa, and makes the FDA I believe that the products imported in the future are in line with the regulations This may require a letter detailing the corrective actions taken and providing relevant documentation For guidance on how to remove names from dwpe, please refer to Chapter 9 of the FDA regulatory procedures manual, "retention without physical examination (dwpe)." Attachment: Chinese enterprises listed in dwpe import warning (red list) * [update]: