Japan Issues Minor Changes to FMA Application
On October 8, 2010, the Pharmaceuticals and Medical Device Agency (PMDA) of Japan’s Ministry of Health, Labour and Welfare (MHLW) released Notification 1008 No. 1.
With this notification, marketing authorization holders (MAHs) who are involved in the foreign manufacturer accreditation (FMA) process must become more aware of the foreign manufacturer’s other MAHs and products. In the revised FMA application, the “Product and Process List” Form requires details on all of the foreign manufacturer’s products in Japan and the products’ corresponding MAH.
This notification also included updates on the medical certificate requirement for the foreign manufacturer’s representatives involved in the manufacturing process. In the previous FMA application guidelines, a medical certificate from the manufacturing site’s country was required for each company representative involved in the manufacturing process. More recently, a change was implemented where under “unavoidable” and “reasonable” circumstances, the medical certificate could be substituted with a signed and written statement. Now with Notification 1008 No.1, under “unavoidable” and “reasonable” circumstances, a single representative for the foreign manufacturer who agrees to assume responsibility may submit a single signed and written statement. This single signed and written statement would replace the medical certificate for all of the company’s representatives who are involved in the manufacturing process.
A number of other changes, such as formatting, were made to numerous forms in the FMA application. For example, the “Outline of Buildings and Facilities” form and the “Utilization of Other Testing and Inspection Facilities” form were altered.
China SFDA Releases Common Technical Document Dossier Format for Pharmaceutical Registration Applications
The SFDA issued “Requirements on Application Dossiers in Common Technical Document (CTD) Format for Pharmaceutical Products” in late September 2010.
The release of this CDT format for Pharmaceutical Registration Applications continues China’s trend of integrating with international regulatory standards. Through further integration, greater quality of research and development in China’s drug sector is expected.
The drug CDT requirements drew significantly from the Common Technical Document (CTD) from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
As an addendum to this release, the SFDA has included some key points to note. Most importantly, Attachment 2 of “Provisions for Drug Registration” SFDA Order No. 28 must still be referenced. The SFDA appears to be presenting the CTD as a secondary format at the moment. In other words, applicants may consult the CTD for registration application sections for drug registration in China, but Attachment 2 of “Provisions for Drug Registration” will be the primary guideline. For example, application sections 3, 4, and 5 on manufacturing in Attachment 2 of “Provisions for Drug Registration” can be met by using the CTD format. However, the SFDA will not accept clinical trials sections in CDT format.
“Requirements on Application Dossiers in Common Technical Document (CTD) Format for Pharmaceutical Products”(Chinese) can be downloaded on China’s SFDA website. The Chinese version of Attachment 2 of “Provisions for Drug Registration SFDA Order No. 28 can also be accessed on the SFDA website.
Updates on India’s Medical Regulations
The CDSCO has recently published on their website the “National List of Drug Manufacturers / Loan Licensee and Certificate of Pharmaceutical Product (COPP) Holders,” the “National List of Approved Testing Laboratories,” and the “Capacity of Testing Laboratories under the CDSCO.”
The first document outlines the number of original licensees, number of loan licensees, and the number of COPP holders. This information covers each of the 29 Indian states and 5 union territories. Additionally, the document provides information on the manufacturing sites and the COPP holders themselves. The document details the name of the manufacturing site, the address, the manufacturing license number, validity period, and the categories of products that are permitted. This CDSCO update serves as a very useful resource since companies can now see that drug manufacturing is most robust in the western parts of India (e.g. the states of Gujarat and Maharashtra).
The National List of Approved Testing Laboratories lists the names, addresses, and contact information of all approved testing laboratories. The list is divided by the different states of India. The Capacity of Testing Laboratories under the CDSCO lists the total testing capacity of all labs in India.
The Drug Controller General of India (DCGI) has also proposed to the Health Ministry to establish advisory drug panels to determine the “desirability” of new drugs and vaccines before new drug and biotech approvals, and clinical trial approvals. These committees will be made up of pharmacologists and specialists that can provide expert opinion on issues related to how essential certain drugs are to the Indian market.
Philippines Releases Administrative Order Draft of GMP for Foreign Manufacturers
Philippines’ Food and Drug Administration (FDA) under the Department of Health requested comments on a draft of the new administrative order for GMP of foreign drug manufacturers. The guidelines serve to establish a formal system of evaluation, monitoring, and assurance for GMP compliance by foreign drug manufacturers. Furthermore, importers based in the Philippines will also be required to follow this order since several clauses importers to act to prevent non-GMP cleared pharmaceuticals from entering the country. The order builds off of Administrative Order 43 s. 1999 – cGMP for drugs that currently governs domestic manufacturers.
This GMP administrative order focuses on four key objectives:
- The Philippines’ FDA will release guidelines to standardize submission, review, monitoring, and archiving of GMP documents by foreign manufacturers.
- Importers must confirm GMP clearance of each product before the product begins the registration process.
- The importer continues to take on a key role by following up on the GMP of the foreign manufacturer. Evidence will need to be presented to the Philippines’ regulatory bodies periodically.
- Foreign drug manufacturers must now allow the Philippines’ FDA to conduct GMP audits.
Foreign manufacturers currently producing drugs in the Philippines should begin preparations for abiding by the Philippines’ new GMP requirements.
