Medical regulatory information to be exchanged between Japan and Singapore
The Health Sciences Authority (HSA) of Singapore and the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labor and Welfare (MHLW) together with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan met in Singapore to sign an agreement that states that parties involved will exchange information on regulations with regards to drugs, medical devices, and cosmetics (quasi-drug included).
The regulatory information that will be exchanged includes advance drafts of legislation and regulatory guidance documents, as well as information pertaining to the authorization and supervision of medical products for human use. All parties of this agreement are to adhere to the confidentiality of the exchanged information.
The purpose of this agreement is to improve pre- and post-market regulatory issues of medicines, medical devices and cosmetics, to allow both parties of the agreement to acquire an understanding of the other party’s regulations, and to guarantee the safety and efficacy of medicines, medical devices, and cosmetics in both Singapore and Japan.
However, there are limitations to this exchange of information. Some occasions in which the dissemination of information will be limited are if it leads to disclosure of a trade secret, or is inconsistent with respective laws or public interest.
The agreement took effect on May 15 and was signed by the Chief Executive Officer of the HSA, the Director-General of the Pharmaceutical and Food Safety Bureau of the MHLW, and the Chief Executive of the PMDA.
Fast-tracked registration process for Indian generic drugs in Singapore
During a bilateral India-Singapore Comprehensive Economic Cooperation Agreement (CECA) review meeting on May 11, 2010, representatives of both parties signed an agreement to allow easier access for Indian generic (off-patent) drugs in Singapore.
The Indian commerce and industry minister Anand Sharma and Lim Hng Kiang of Singapore signed the “Special Scheme For Registration Of Generic Medicinal Products From India.” The purpose of the agreement is to speed up the registration and approval process for Indian generic drugs.
Previous to this agreement, Indian drug manufacturers could not export generic drugs to Singapore without undergoing clearances. However, under this new agreement, if the US, EU, Canada, or Australia has approved the Indian drug, then it will not need any more clearances to enter the Singaporean market.
India is currently the fourth largest producer of generic drugs in the world. It is a $25 billion industry. Its presence in the global market has cut down the cost of life-saving drugs. The hope is that this agreement will not only speed up the registration process for generic drugs, but also will promote further harmonization in generic drug certification.
Philippines: Automatic Renewals of Licenses to Operate
In March 2010, the Philippine Bureau of Food and Drugs (BFAD) announced that it will be issuing Automatic Renewals for Licenses to Operate (LTO) that are set to expire within the end of this year. These LTOs are those belonging to registered drug and medical device manufacturers under Regulation Division II. These renewals will be issued without any required inspection.
The Application for Automatic Renewal will be accepted 3 months before the LTO expiry date. The entity that is seeking this Automatic Renewal must fulfill the following:
- Be operational for at least one year
- Have no violative products reported for the past year
- Have latest issuance of LTO not earlier than 2008
- Have valid contracts of the following as required:
- Manufacturing Agreements with toll manufacturers (for traders only)
- Contract of Lease for plant site/office site
- Warehouse (if located separately)
- Have a pharmacist of good standing (rendering full time service) for the past year, if applicable
- No previous noted deficiencies
- Have systemized distribution records (whether manual or computerized recording)
- Have compilation of relevant SOPs
Additional criteria for manufacturers:
- Must have been inspected last year (2009) with no deficiencies or CAPA has been verified satisfactorily
- Must have no changes in its updated Site Information File (SIF)
Those applying for renewal should pay renewal fees and submit the following supplemental documents:
- An application letter for renewal of LTO and photocopy of Official Receipt for renewal payment
- An affidavit attesting that the company has no changes in its operation and set-up, in order to avail of the said automatic renewal
Regulatory cooperation agreement signed between China SFDA and Hong Kong DOH
The Chinese SFDA and the DOH of Hong Kong signed an agreement that details future cooperation and communication with regards to medical device and pharmaceutical regulations. The Director of the DOH Dr. P. Y. Lam and SFDA Commissioner Mr. Shao Mingli met in late May to sign this agreement.
According to Dr. Lam, this agreement will act to enhance the regulatory control of drugs and medical devices between Hong Kong and mainland China. Hong Kong has been a Special Administrative Region (SAR) of the People’s Republic of China (PRC) since July 1997.
This increased cooperation is in the interest of both people in mainland China and Hong Kong. The public in these two places have high expectations for medical devices, Chinese medicines, and Western medicines.
The agreement includes enhanced cooperation on the following regulatory issues:
- Regulation and registration of Chinese medicines, drugs, medical devices
- Safety information and GMP
- Clinical trial monitoring with regards to Western and Chinese medicines
- Training of personnel
This meeting also established that working meetings will be held in the future when necessary.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at info@pacificbridgemedical.com.
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