What is "AFM" ？
'AFM' is short for 'Accreditation of Foreign Manufacturers', which is usually called' Foreign manufacturer's Accreditation '.Some manufacturers of pharmaceuticals, quasi-drugs and medical apparatus and instruments abroad in Japan need to Accredited Foreign manufacturers (MHLW), according to ARTICLE 13-3 of pharmaceutical law, if they want to produce some relevant products to the Japanese
market. Domestic companies need to be recognized by the ministry in the same way. To put it simply, AFM accreditation is for manufacturing sites, similar to the way we obtain drug manufacturing licenses.
As far as API business is concerned, AFM that it is the first drug regulatory barrier to enter the Japanese market. Any pharmaceutical
manufacturer wishing to export API or intermediates to the Japanese market needs to obtain AFM certification first, and has obtained
a "company code" and "business code".
When do the registration of AFM, will the Japanese authorities go to the factory for on-site inspection?
in principle, the AFM needs inspectors from the ministry of labor, health and welfare should also be sent to the factory for on-site
inspection to confirm the production of hardware facilities and software systems. However, for a variety of reasons, when determining AFM and updating AFM, it is generally file checking.
What documents should be submitted to Japanese authorities when applying for AFM accreditation?
the information required by AFM is very simple and does not take much time to prepare. Generally speaking, the following information is required:
Information submitted by AFM:
(1) application for Japanese version (prepared by Japanese agent and signed by Chinese manufacturer)
(2) the medical examination certificate or self-declaration from the representative of production site
(3) resumes of the Head of production and the Head of quality
(4) product catalog and process flow chart
(5) Form I of facilities and buildings (including company plan, workshop plan, finishing and packing plan, QC plan, warehouse plan,
and corresponding area.)
(6) questionnaire about production sites
(7) organization chart
(8) scanned copy of production license and English translation
(9) GMP certificate issued by the local government
(10) the translator's statement
(11) letter of authorization
The validity period of AFM?
the AFM is valid for 5 years and needs to be renewed every 5 years. The information submitted for update is approximately the same
as that initially identified.
Is AFM identification required for each product?
of course not. Not every product needs to be identified by AFM separately. The identification of AFM is for the production site. Once
the Japanese official permits are obtained, the AFM certificate is obtained. The AFM identification number may be cited for products
of the same category produced within the premises without the need to repeat the identification.
Moreover, Japanese regulations do not allow repeated identification of the same production site
What is the price for registration of AFM?
in terms of AFM accreditation, there are five situations involving fees: new accreditation of AFM (application for AFM accreditation for
the first time), renewal of AFM (renewal of AFM accreditation every five years), increase/change of categories of accreditation of
AFM, and certificate issuance. The cost varies depending on whether it is a site inspection or a document inspection.
The fees determined by AFM are as follows:
|Foreign manufacturer recognized inspection
fee classification fee (JPY)
|New AFM (on site)
|New AFM (file)
|AFM update (on site)
|AFM update (file)
|Additional categories identified (on site)
|Additional categories identified (file)
|Changes in identified categories (on site)
|Changes in identified categories (file)
|Issue of AFM certification
|Reissue of AFM certificate
In general, based on the business cooperation between the two sides, our company and the Japanese agent KOA SHOJI carry out
AFM identification and AFM maintenance for our partners for free.
Commissioned by overseas pharmaceutical companies to
conduct thorough market research in China and raise high
quality raw materials and fine chemical products.
Help customers to grasp the market demand in time, looking for products to
meet customer requirements in China. For example, for original drugs whose
patent expires in 2015, foreign customers often start to look for excellent active
ingredients 4-5 years before the patent expires. We can provide comprehensive
market research services to help customers understand Chinese manufacturers
and their products.
To ensure a steady supply of products, to provide high
quality products to meet the customer's highest quality requirements.
1. we will screen out the suppliers with the best quality through cooperation with
the external testing institutions.
2. assist customers to cooperate with suppliers with international level of drug
3. promote smooth communication and pleasant cooperation between custom
-ers and suppliers.