- Data on local irritation.
- Other safety data.
(e) Data on pharmacological action:
- Other safety data.
- Data on efficacy (mechanism of action).
- Data on safety (general pharmacology).
- Other animal pharmacology data.
(f) Data on pharmacokinetics (PK):
- Data on absorption.
- Data on distribution.
- Data on metabolism.
- Data on excretion.
- Data on bioequivalence.
- Other PK data.
- Data on the results of clinical trials.
Some of these requirements are omitted when
applying for a new dosage, a new indication, a
new route of administration or a new formulation
withregard to adrug already approved, or may vary
according to drug classification, non-prescription
drug (Notification 0827003 from PSFB, 27 August
2003), quasi-drug or cosmetic.
Quality standards
Quality standards for substances and devices
regarding properties, technical specifications
and test methods
- The Japanese Pharmacoepia (JP). The main and
the oldest document specifying standards for
drugs is the JP, first published in 1886. The JP is
established by law (Article 41). It aims at regulat-
ing quality for important drugs used in healthcare
and specific standard test methods. The JP is
revisedbylawevery10years;butinpractice,
the revision is carried out every 5 years.
The fourteenth edition was published in 2001
and already contains some monographs harmo-
nized with the US and European Pharmaco-
poeias. The fifteenth edition was issued in 2006.- For drugs not mentioned in the JP, Article 42 of
the PAL indicates that the MHLW can lay down
necessary standards for drugs and so on, requir-
ing particular cautions. The following standards
for drugs have been gazetted throughministerial
ordinance:
(a) Standards for Biological Materials (MHLW
Notification 210, 2003).(b) Minimum requirements for biological
products.(c) Minimum requirements for blood grouping
antibodies.(d) Radiopharmaceutical standards.Other standards were published for quasi-drugs
(e.g. sanitary products standards), cosmetics (e.g.
standards for the quality of cosmetics) and medical
devices (e.g. standards for blood donor sets, for
cardiac pacemakers, for medical X-ray apparatus).- For substances not mentioned in the JP and not
covered by Article 42 of the Law, additional
standards were notified by the MHLW, for
example, the Japanese standards for pharma-
ceutical ingredients, standards for crude drugs,
standards of raw materials for clinical diagnos-
tics and so on. - Finally, for drugs having particular manufacturing
technology and test methods, such as biotechno-
logical products, a government certification based
on ‘batch tests’ is necessary.
35.3 DRUG DEVELOPMENT REGULATIONS OVERVIEW 495