Transcript Link between legal framework of VMP regulation and VICH GLs in Japan

Link between legal framework of VMP
regulation and VICH GLs in Japan
Takashi Kozasa DVM
Ministry of Agriculture, Forestry and Fisheries
Government of Japan
Topics
1. Legal Framework of VMP
Regulation in Japan
2. Implementation of VICH GLs
in Japan
Topics
1. Legal Framework of VMP
Regulation in Japan
2. Implementation of VICH GLs
in Japan
Pharmaceutical Affairs Act
(Act No.145 of 1960)
• Purpose of the Act is
- to regulate matters pertaining to drugs, quasi-drugs,
cosmetics and medical devices.
- to ensure their quality, efficacy and safety.
- to regulate each stage of development, manufacturing
(importing), marketing, retailing and usage.
• The same Act regulates medicinal products
for human use (MPs) and veterinary
medicinal products (VMPs)
Marketing Approval of Medicinal Products
[Article 14]
A person intending to market a pharmaceutical
product (including biological), quasi-drug,
cosmetic or medical device shall, for each
product, obtain marketing approval of the
Minister with respect to its marketing.
 The approval shall not be granted when the drug;
• does not possess effects indicated in the dossier,
• has harmful action outweighing its effects,
• does not have appropriate quality.
 Before providing an approval, the Minister shall seek the
opinion of the Pharmaceutical Affairs and Food
Sanitation Council (PAFSC).
Ministers in charge of Medicinal-Products
administration
Minister of Health,
Labor and Welfare
(MHLW)
Minister of
Agriculture,
Forestry and
Fisheries (MAFF)
Medicinal products for
human use (MPs)
Medicinal products
exclusively used for
animals (VMPs)
non-binding
Legally-binding
Legal Cascade for VMPs in Japan
PHARMACEUTICAL
AFFIARS ACT
(No.145, 1960)
Top legislation for medicinal products in Japan
Applicable for both MPs and VMPs
MAFF Ministerial
Ordinances
Regulatory rules specific to VMPs
(GLP, GCP, GMP, etc.)
MAFF Ministerial
Announcements
Biological products standard
National-Assay standard, etc.
Notice
from MAFF-HQ Director General or Director
from NVAL Director General
(including GUIDELINEs)
Topics
1. Legal Framework of VMP
Regulation in Japan
2. Implementation of VICH GLs
in Japan
Guidelines contribute faster
approval of new VMPs
Issues on new drug development
Guidelines
• Specification of quality and stability
• Method for establishing
is unknown due to physical
specification and stability study
/chemical properties of VMP
• Evaluation method is unknown due
to new mechanism of action
• Efficacy parameter setting and
• Difficult to assess the efficacy due
study design
to mild or slow action
For Applicant: Encourage new research & development in lower cost
For RA: Shorten reviewing period of time
For User: Increase options for veterinary service,
improve animal health and secure food safety
Use guidelines at each stage
from dossier preparation to approval, if the study design in
the dossier is scientifically relevant
Dossier prep
Applicant
Submission
Review
Approval
Regulatory Authority
Seek opinion
Report
Pharmaceutical Affairs and
Food Sanitation Council
Application for marketing approval of VMPs
=Application Form=
1. Name and Address of Manufacturer
2. License No. & Address of Manufacturer
3. Type of License
4. Name of VMP
5. Name, quantities, acceptance criteria of
active ingredients and excipients
6. Manufacturing Method
7. Dosage and Administration
8. Properties of the VMP
9. Condition for storage
10. Period of validity
11. Acceptance criteria and Test Procedures
12. References
GUIDELINEs
GUIDELINEs
With sets of
examination data
Implementation of VICH GLs
• VICH GLs are implemented in Japan as
notices (legally non-binding).
• In addition, we amended ministerial
ordinances and/or ministerial announcements
for the smooth implementation of some GLs.
Implementation of TABST GL (1)
• GL50 (Waiver for TABST) after translated
into Japanese was implemented in Japan as
notice in February, 2014.
• Issued explanation notice of the Director of
the National Veterinary Assay Laboratory.
• Amended the Ministerial Announcement
(Biological products standard) to implement
the GL smoothly.
Implementation of TABST GL (2)
• “Test procedures” of batch release
(including TABST) are approved under the
Pharmaceutical Affairs Act.
• To waive the TABST, MAHs have to apply
for the approval of the MAFF.
• Detailed explanation to the Industry is in
the notice of the Director of the NVAL.
For more detail on the content of this guideline, please refer to Dr. Endo’s
presentation tomorrow (Session2; agenda item #10.3).
VICH GLs
• JMAFF regards VICH GLs as important tools to
accelerate the approval of VMPs
• RA and Industry work together throughout the
creation steps as an equal partner
– A mutual agreement between RA and industry
– Maximum study design
• Published as Notice
– Legally non-binding (recommendation)
– In Japanese, with critical translation check by the Experts
• Lead both applicant and reviewer to the goal
– Faster approval
– Benefit also to veterinarians & users
(Ref) Revision of Pharmaceutical Affairs Act
(effective since Nov. 2014)
Before
Chapter for Medicinal Products and
Medical Devices
-Pharmaceuticals
-Biologicals
-Diagnostics
-Surgical devices
-Imaging devices
etc.
-Artificial tissues
(skin, cartilage)
After
Chapter for Medicinal Products
-Pharmaceuticals
-Biologicals, etc.
Chapter for Medical Devices
-Surgical devices
-Imaging devices
-Diagnostics, etc.
Chapter for Regenerative Medicinal
Products
-Stem cells
-Immune cells
-Artificial tissues, etc.