Pharmaceutical Administration and Regulations in Japan - Nihs

selling, leasing, or giving.
Biological products and specified
biological products are specified by the
Minister of Health, Labour and Welfare in its
Ordinance No. 209 issued in 2003 and
Notification No. 0520001 of the PFSB dated
May 20, 2003 that came into effect on July
30, 2003.
Based on the provisions in the Law for
biological products and specified biological
products, the “Manufacturing Supervisors
and Import and Marketing Supervisors for
Biological Products,” “Labeling on the
Immediate Container or Packaging,” “Entries
in the Package Inserts (Notification No.
0515005 of the PFSB dated May 15,
2003),” ”Periodic Infection Reporting System
(Notification No. 0515008 of the PFSB dated
May 15, 2003),” ”Records and Their
Retention,” “Outsourcing of Records and
Their Retention,” “Dissemination of
Information,” and “Manufacturing Control and
Quality Control” are specified in Notification
No. 0515017 of the PFSB dated May 15,
2003 and Notification No. 0520004 of the
PFSB dated May 20, 2003, etc.
The basic technical requirements to
assure the quality and safety of drugs and
medical devices processed from
human-derived (autologous) cells and tissues
are specified in Notification No. 0208003 of
the PFSB dated February 8, 2008. On
March 27, 2008, Notification No. 0327027 of
Pharmaceutical Regulations in Japan:
the Compliance and Narcotics Division,
PFSB on manufacturing control and quality
control of drugs and medical devices
processed from human-derived (autologous)
cells and tissues was issued. The basic
technical requirements to assure the quality
and safety of drugs and medical devices
processed from human-derived
(homologous) cells and tissues are specified
in Notification No. 0912006 of the PFSB
dated September 12, 2008. Notification No.
0420-(1) of the Evaluation and Licensing
Division, PFSB dated April 20, 2010 entitled
“Guidelines for the preparation of
applications to verify quality and safety of
drugs and medical devices processed from
cells and tissues” was issued.
3.3 Licenses for Marketing Businesses
and Manufacturing Businesses
1) Licenses for marketing businesses
Person wishing to start marketing
business for drugs, quasi-drugs, cosmetics,
or medical devices must obtain a marketing
business license of the prefectural governor
depending on the type of business. These
licenses are of the following seven types.
(1) Type 1 drug marketing business
license: Marketing of prescription
drugs
(2) Type 2 drug marketing business
license: Marketing of drugs other
than prescription drugs
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