On 18 March 2010, China’s Ministry of Health officially announced the Regulating Measures on Pharmaceutical Precursor Chemicals (Measures). The Measures took effect on 1 May 2010. As a result, China’s Food and Drug Administration (FDA) issued a Circular on Re-Issuance of Permits to Enterprises Manufacturing and Operating Pharmaceutical Precursor Chemicals (Circular) on 4 June 2010, specifying the implementation of the administration of the manufacture and operation of pharmaceutical precursor chemicals outlined in the Measures.
Background
Pharmaceutical precursor chemicals, such as lysergic acid, ergotamine, ergonovine, ephedrine and some ephedrine-related products, can be used to produce drugs illegally. The Measures are promulgated to strengthen the administration of pharmaceutical precursor chemicals, avoid inflow of the chemicals to the illegal drug market and clarify the division of authority among relevant governmental departments.
The Measures
The Measures include eight chapters and 50 articles, and the main contents are as follows:
- Providing the scope, conditions, procedures, documents and approving time limits of applying for manufacture, operation and purchase permits of pharmaceutical precursor chemicals
- Specifying the sales channel for active pharmaceutical ingredients of pharmaceutical precursor chemicals, ephedrine of single-ingredient preparations and small packages
- Standardizing the system and conditions for safety management of the manufacture, operation and use of pharmaceutical precursor chemicals
The Circular
The Circular is an assisting regulation specifying the implementation of some sections in the Measures. More specifically, the Circular dictates that all enterprises that obtained a permit for manufacture and operation of pharmaceutical precursor chemicals before the Measures must re-apply for such permit to the local FDA within three months after the issuance of the Circular. The FDA will examine the application documents and make onsite inspections to the applicant according to the conditions and standards outlined in the Measures.
If enterprises with old permits do not make an application or obtain a new permit, they are not allowed to manufacture or purchase as of 1 September 2010, although their then-current inventory is still allowed to be sold.
Furthermore, the Circular provides for some conditions in which the new permit will not be issued. Such conditions include the failure to obtain or maintain a Good Supply Practice (GSP) certificate, the conviction of the enterprise’s legal representative or other employees for drug-related crimes, fraud in the application documents and failure to pass the annual check by the Administration for Industry and Commerce.
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