This document summarizes key pharmaceutical regulatory bodies and standards organizations: 1. The Bureau of Indian Standards (BIS) regulates pharmaceutical standards in India. 2. The International Organization for Standardization (ISO) is an international standard-setting body that develops voluntary standards for businesses and technologies, including some related to pharmaceuticals. 3. The U.S. Food and Drug Administration (USFDA) regulates food, drugs, medical devices, and other products in the United States and cooperates internationally on regulatory issues.

1. Pharmaceutical industrial management
Standard institutions and regulatory authorities.
By: - Drx Jayesh.M.Rajput
Points:-
1. Bureau of Indian standards (BIS)
2. International organization for standardization (ISO)
3. United states food and drug administration (USFDA)
4. Central drug standard control organization (CDSCO)
5. International conference on harmonization (ICH)
6. World health organization (WHO)
7. Ministry of health, labour and welfare (MHLW)
1. Bureau of Indian standards (BIS)
The Bureau of Indian Standards (BIS) is the national Standards Body of India working under the aegis of
Ministry of Consumer Affairs, Food & Public Distribution, Government of India. It is established by the Bureau of
Indian Standards Act, 1986 which came into effect on 23 December 1986.[2] The Minister in charge of the Ministry
or Department having administrative control of the BIS is the ex-officio President of the BIS. The organisation was

2. formerly the Indian Standards Institution (ISI), set up under the Resolution of the then Department of Industries
and Supplies No. 1 Std.(4)/45, dated 3 September 1946. The ISI was registered under the Societies Registration
Act, 1860. As a corporate body, it has 25 members drawn from Central or State Governments, industry, scientific
and research institutions, and consumer organisations. Its headquarters are in New Delhi, with regional offices in
Kolkata, Chennai, Mumbai, Chandigarh and Delhi and 20 branch offices. It also works as WTO-TBT enquiry point
for india. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious
development of the activities of standardization, marking and quality certification of goods and for matters
connected therewith or incidental thereto.BIS has been providing traceability and tangibility benefits to the national
economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers;
promoting exports and imports substitute; control over proliferation of varieties etc. through standardization,
certification and testing.
Keeping in view, the interest of consumers as well as the industry, BIS is involved in various
activities as given below:
 Standards Formulation
 Product Certification Scheme
 Compulsory Registration Scheme
 Foreign Manufacturers Certification Scheme
 Hall Marking Scheme
 Laboratory Services
 Laboratory Recognition Scheme
 Sale of Indian Standards
 Consumer Affairs Activities
 Promotional Activities
 Training Services, National & International level
 Information Services
BIS has its Headquarters at New Delhi and its 05 Regional Offices (ROs) are at Kolkata (Eastern), Chennai
(Southern), Mumbai (Western), Chandigarh (Northern) and Delhi (Central). Under the Regional Offices
are the Branch Offices (BOs) located at Ahmedabad, Bangalore, Bhubaneswar, BhopaSl, Coimbatore,
Dehradun, Faridabad, Ghaziabad, Guwahati, Hyderabad, Jaipur, Kochi, Lucknow, Nagpur, Parwanoo,
Patna, Pune, Rajkot, Raipur, Durgapur, Jamshedpur and Vishakhapatnam, which offer certification
services to the industry and serve as effective link between State Governments, industries, technical
institutions, consumer organization etc. of the respective region.
BIS Act, Rules & Regulations
 BIS Rules, 2018 incorporating Amendment No. 1
 The BIS Rules, 2018
 The Bureau of Indian Standards (Conformity Assessment) Regulations, 2018
 The Bureau of Indian Standards (Advisory Committees) Regulations, 2018
 The Bureau of Indian Standards (Hallmarking) Regulations, 2018
 The Bureau of Indian Standards (Powers and Duties of Director General) Regulations, 2018
 Notification on precious metal articles to be marked with hallmark, notified by Department of Consumer
Affairs
 Enforcement of BIS Act, 2016
 Continuation of Regulations/Orders made under BIS Act, 1986
 The BIS Act, 2016

3.  Notification of BIS Rules, 2017
 The BIS Act, 1986
 The BIS Rules, 1987
 The BIS (Appointment, Terms and Conditions of Service of Director-General) Rules, 1987
 The BIS (Recognition of Consumers’ Associations) Rules, 1991
 The BIS (Powers and Duties of Director-General) Regulations, 1987
 The BIS (Advisory Committees) Regulations, 1987
 The BIS (Certification) Regulations, 1988
 The BIS (Recruitment to Scientific Cadre) Regulations, 2002
 The BIS (Recruitment to Laboratory Technical Posts) Regulations,2007
 The BIS (Terms and Conditions of Service of Employees), Regulations, 2007
 The BIS (Recruitment to Administration, Finance and Other Posts) Regulations,
2007
2. International organization for standardization (ISO)
The International Organization for Standardization (ISO /ˈaɪsoʊ/) is an international standard-setting
body composed of representatives from various national standards organizations. Founded on 23 February
1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is
headquartered in Geneva, Switzerland,[3]
and works in 164 countries.It was one of the first organizations
granted general consultative status with the United Nations Economic and Social Council.
The International Organization for Standardization is an independent, non-governmental organization, the
members of which are the standards organizations of the 164[1]
member countries. It is the world's largest
developer of voluntary international standards and facilitates world trade by providing common standards
between nations. Over twenty thousand standards have been set covering everything from manufactured
products and technology to food safety, agriculture and healthcare.Use of the standards aids in the
creation of products and services that are safe, reliable and of good quality. The standards help businesses
increase productivity while minimizing errors and waste. By enabling products from different markets to
be directly compared, they facilitate companies in entering new markets and assist in the development of
global trade on a fair basis. The standards also serve to safeguard consumers and the end-users of
products and services, ensuring that certified products conform to the minimum standards set
internationally
Structure
ISO is a voluntary organization whose members are recognized authorities on standards, each
one representing one country. Members meet annually at a General Assembly to discuss ISO's
strategic objectives. The organization is coordinated by a Central Secretariat based in Geneva
A Council with a rotating membership of 20 member bodies provides guidance and governance,

4. including setting the Central Secretariat's annual budget. The Technical Management Board is
responsible for over 250 technical committees, who develop the ISO standards.[10][12][13][14]
IEC joint committees
ISO has formed two joint committees with the International Electrotechnical Commission (IEC)
to develop standards and terminology in the areas of electrical and electronic related
technologies.
ISO/IEC JTC 1
ISO/IEC Joint Technical Committee 1 (JTC 1) was created in 1987 to "[d]evelop, maintain,
promote and facilitate IT standards",[15]
where IT refers to information technology.
ISO/IEC JTC 2
ISO/IEC Joint Technical Committee 2 (JTC 2) was created in 2009 for the purpose of
"[s]tandardization in the field of energy efficiency and renewable energy sources".[16]
Membership.
ISO has 163 national members.[1]
ISO has three membership categories:[1]
 Member bodies are national bodies considered the most representative standards body in each
country. These are the only members of ISO that have voting rights.
 Correspondent members are countries that do not have their own standards organization. These
members are informed about ISO's work, but do not participate in standards promulgation.
 Subscriber members are countries with small economies. They pay reduced membership fees, but
can follow the development of standards.
Participating members are called "P" members, as opposed to observing members, who are called "O"
members.
Products named after ISO
The fact that many of the ISO-created standards are ubiquitous has led, on occasion, to common use of
"ISO" to describe the actual product that conforms to a standard. Some examples of this are:
 Many CD images end in the file extension "ISO" to signify that they are using the ISO 9660
standard file system as opposed to another file system—hence CD images are commonly referred
to as "ISOs". Virtually all computers with CD-ROM drives that can read CDs use this standard.
Some DVD-ROMs also use ISO 9660 file systems.
 Photographic film's sensitivity to light (its "film speed") is described by ISO 6, ISO 2240 and
ISO 5800. Hence, the film's speed is often referred to by its ISO number.

5.  As it was originally defined in ISO 518, the flash hot shoe found on cameras is often called the
"ISO shoe".
 ISO 11783, which is marketed as ISOBUS.
 ISO 13216, which is marketed as ISOFIX.
3. United states food and drug administration (USFDA)
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States
Department of Health and Human Services, one of the United States federal executive departments. The
FDA is responsible for protecting and promoting public health through the control and supervision of
food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical
drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic
radiation emitting devices (ERED), cosmetics, animal foods & feed[4]
and veterinary products.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and
Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws,
notably Section 361 of the Public Health Service Act and associated regulations, many of which are not
directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of
disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and
consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott
Gottlieb, M.D. is the current commissioner, who took over in May 2017.[5]
The FDA has its headquarters in unincorporated White Oak, Maryland.[6]
The agency also has
223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin
Islands, and Puerto Rico.[3]
In 2008, the FDA began to post employees to foreign countries,
including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.[7]
Organizational chart
 Department of Health and Human Services
o Food and Drug Administration
 Office of the Commissioner
 Office of Operations[9]
 Office of Equal Employment Opportunity
 Office of Human Resources
 Office of Finance, Budget and Acquisition
 Office of Information Management and Technology
 Office of Informatics & Technology Innovation
 Director: Taha A. Kass-Hout (also holds post of
Chief Health Informatics Officer for the FDA)[10][11]
 Office of Information Management

6.  Office of Security Operations
 Office of Facilities Engineering and Mission Support Services
 Office of Policy, Planning, Legislation, and Analysis
 Office of Medical Products and Tobacco
 Center for Biologics Evaluation and Research (CBER)
 Center for Devices and Radiological Health (CDRH)
 Center for Drug Evaluation and Research (CDER)
 Center for Tobacco Products (CTP)
 Office of Foods and Veterinary Medicine
 Center for Veterinary Medicine (CVM)
 Center for Food Safety and Applied Nutrition (CFSAN)
 Office of Global Regulatory Operations and Policy (GO)
 National Center for Toxicological Research (NCTR)
 Office of Regulatory Affairs
Regulatory programs
As of 2015, the agency regulates more than $1 trillion in consumer products, including:
 $466 billion in food
 $275 billion in drugs
 $60 billion in cosmetics
 $18 billion in vitamin supplements
 It also regulates…..
Food and dietary supplements, "FDA-Approved" vs. "FDA-Accepted in Food Processing"
, Medications, New medications, Advertising and promotion, Postmarket safety surveillance
, Generic drugs, Generic drug scandal, Over-the-counter drugs, Ebola treatment
, Vaccines, blood and tissue products, and biotechnology, Medical and radiation-emitting devices,
"FDA-Cleared" vs "FDA-Approved", Cosmetics, Veterinary products
, Tobacco products, Regulation of living organisms, International Cooperation
, Science and research programs, Data management.
Location
In recent years, the agency began undertaking a large-scale effort to consolidate its 25 operations in
the Washington metropolitan area, moving from its main headquarters in Rockville and several
fragmented office buildings to the former site of the Naval Ordnance Laboratory in the White Oak
area of Silver Spring, Maryland.[6][12]
The site was renamed from the White Oak Naval Surface
Warfare Center to the Federal Research Center at White Oak.

7. 4. Central drug standard control organization (CDSCO).
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for
Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines
Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United
States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical
devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug
Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal
offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when
needed.
Though the CDSCO has a good track record with the World Health Organization,[5]
it has also been
accused of past collusion with independent medical experts and pharmaceutical companies. CDSCO plans
to open international offices in Beijing, China.
The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health
Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority
(NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has
six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the
country.
The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state
regulators for regulation of drugs & cosmetics.It envisages uniform implementation of the provisions of
the Act & Rules made there under for ensuring the safety, rights and well being of the patients by
regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency,
accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical
product manufactured, imported and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical
Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and
coordination of the activities of State Drug Control Organizations by providing expert advice with a view
of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Further CDSCO along
with state regulators, is jointly responsible for
grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V.
Fluids, Vaccine and Sera.

8. ,

10. 5. International conference on harmonization.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry
to discuss scientific and technical aspects of pharmaceutical product development and registration.
The mission of the ICH is to promote public health by achieving greater harmonisation through the
development of technical Guidelines and requirements for pharmaceutical product registration.[1]
Harmonisation leads to a more rational use of human, animal and other resources, the elimination of
unnecessary delay in the global development, and availability of new medicines while maintaining
safeguards on quality, safety, efficacy, and regulatory obligations to protect public health.
Structure
The ICH comprises the following bodies:[6]
1. ICH Assembly
2. ICH Management Committee
3. MedDRA Management Committee
4. ICH Secretariat
The ICH Assembly brings together all Members and Observers of the ICH Association as the overarching
governing body of ICH. It adopts decisions in particular on matters such as on the adoption of ICH
Guidelines, admission of new Members and Observers, and the ICH Association’s work plans and
budget. Member representatives appointed to the Assembly are supported by ICH Coordinators who
represent each Member to the ICH Secretariat on a daily basis.
The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of
all Members, including administrative and financial matters and oversight of the Working Groups (WGs).
The MedDRA Management Committee (MC) has responsibility for direction of MedDRA, ICH’s
standardised medical terminology. The MedDRA MC has the role of managing, supporting, and
facilitating the maintenance, development, and dissemination of MedDRA.[7]
The ICH Secretariat is responsible for day-to-day management of ICH, coordinating ICH activities as
well as providing support to the Assembly, the MC and Working Groups. The ICH Secretariat also
provides support for the MedDRA MC. The ICH Secretariat is located in Geneva, Switzerland.
The ICH WGs are established by the Assembly when a new technical topic is accepted for harmonisation,
and are charged with developing a harmonised guideline that meets the objectives outlined in the Concept
Paper and Business Plan. Face-to-face meetings of the WG will normally only take place during the

11. biannual ICH meetings. Interim reports are made at each meeting of the Assembly and made publicly
available on the ICH website.
Process of Harmonisation
ICH harmonisation activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision
Procedure and Maintenance Procedure, depending on the activity to be undertaken. The development of a
new harmonised guideline and its implementation (the formal ICH procedure) involves 5 steps:[8]
Step 1: Consensus building
The WG works to prepare a consensus draft of the Technical Document, based on the objectives set out in
the Concept Paper. When consensus on the draft is reached within the WG, the technical experts of the
WG will sign the Step 1 Experts sign-off sheet. The Step 1 Experts Technical Document is then submitted
to the Assembly to request adoption under Step 2 of the ICH process.
Step 2a: Confirmation of consensus on the Technical Document
Step 2a is reached when the Assembly agrees, based on the report of the WG, that there is sufficient
scientific consensus on the technical issues for the Technical Document to proceed to the next stage of
regulatory consultation. The Assembly then endorses the Step 2a Technical Document.
Step 2b: Endorsement of draft Guideline by Regulatory Members
Step 2b is reached when the Regulatory Members of the Assembly further endorse the draft Guideline.[9]
Step 3: Regulatory consultation and discussion
Step 3 occurs in three distinct stages: regulatory consultation, discussion, and finalisation of the Step 3
Expert Draft Guideline.
 Stage I - Regional regulatory consultation: The Guideline embodying the scientific consensus
leaves the ICH process and becomes the subject of normal wide-ranging regulatory consultation
in the ICH regions. Regulatory authorities and industry associations in other regions may also
comment on the draft consultation documents by providing their comments to the ICH
Secretariat.
 Stage II - Discussion of regional consultation comments: After obtaining all comments from the
consultation process, the EWG works to address the comments received and reach consensus
on what is called the Step 3 Experts Draft Guideline.
 Stage III - Finalisation of Step 3 Experts Draft Guideline: If, after due consideration of the
consultation results by the WG, consensus is reached amongst the experts on a revised version
of the Step 2b draft Guideline, the Step 3 Expert Draft Guideline is signed by the experts of the
ICH Regulatory Members. The Step 3 Expert Draft Guideline with regulatory EWG signatures is
submitted to the Regulatory Members of the Assembly to request adoption at Step 4 of the ICH
process.

12. Step 4: Adoption of an ICH Harmonised Guideline
Step 4 is reached when the Regulatory Members of the Assembly agree that there is sufficient scientific
consensus on the draft Guideline and adopt the ICH Harmonised Guideline.
Step 5: Implementation
The ICH Harmonised Guideline moves immediately to the final step of the process that is the regulatory
implementation. This step is carried out according to the same national/regional procedures that apply to
other regional regulatory guidelines and requirements in the ICH regions.
Information on the regulatory action taken and implementation dates are reported back to the Assembly
and published by the ICH Secretariat on the ICH website
Work products
Guidelines
The ICH topics are divided into four categories and ICH topic codes are assigned according to these
categories:[11]
 Q : Quality Guidelines
 S : Safety Guidelines
 E : Efficacy Guidelines
 M : Multidisciplinary Guidelines
ICH Guidelines are not mandatory for anybody per se but the strength of the ICH process lies in the
commitment for implementation by ICH Regulatory Members using appropriate national/regional tools.
6. World health organization (WHO).
The World Health Organization (WHO) is a specialized agency of the United Nations that is concerned
with international public health. It was established on 7 April 1948, and is headquartered in Geneva,
Switzerland. The WHO is a member of the United Nations Development Group. Its predecessor, the
Health Organisation, was an agency of the League of Nations.
The constitution of the World Health Organization had been signed by 61 countries on 22 July 1946, with
the first meeting of the World Health Assembly finishing on 22 July 1946. It incorporated the Office
International d'Hygiène Publique and the League of Nations Health Organization. Since its establishment,
it has played a leading role in the eradication of smallpox. Its current priorities include communicable

13. diseases, in particular HIV/AIDS, Ebola, malaria and tuberculosis; the mitigation of the effects of non-
communicable diseases such as sexual and reproductive health, development, and aging; nutrition, food
security and healthy eating; occupational health; substance abuse; and driving the development of
reporting, publications, and networking.
The WHO is responsible for the World Health Report, the worldwide World Health Survey, and World
Health Day. The current Director-General of the WHO is Tedros Adhanom, who started his five-year
term on 1 July 2017
Overall focus
The WHO's Constitution states that its objective "is the attainment by all people of the highest possible
level of health".[20]
The WHO fulfills this objective through its functions as defined in its Constitution: (a) To act as the
directing and coordinating authority on international health work; (b) To establish and maintain effective
collaboration with the United Nations, specialized agencies, governmental health administrations,
professional groups and such other organizations as may be deemed appropriate; (c) To assist
Governments, upon request, in strengthening health services; (d) To furnish appropriate technical
assistance and, in emergencies, necessary aid upon the request or acceptance of Governments; (e) To
provide or assist in providing, upon the request of the United Nations, health services and facilities to
special groups, such as the peoples of trust territories; (f) To establish and maintain such administrative
and technical services as may be required, including epidemiological and statistical services; (g) to
stimulate and advance work to eradicate epidemic, endemic and other diseases; (h) To promote, in co-
operation with other specialized agencies where necessary, the prevention of accidental injuries; (i) To
promote, in co-operation with other specialized agencies where necessary, the improvement of nutrition,
housing, sanitation, recreation, economic or working conditions and other aspects of environmental
hygiene; (j) To promote co-operation among scientific and professional groups which contribute to the
advancement of health; (k) To propose conventions, agreements and regulations, and make
recommendations with respect to international health matters and to perform.[citation needed]
As of 2012, the WHO has defined its role in public health as follows:[21]
 providing leadership on matters critical to health and engaging in partnerships where joint
action is needed;
 shaping the research agenda and stimulating the generation, translation, and dissemination of
valuable knowledge;[22]
 setting norms and standards and promoting and monitoring their implementation;
 articulating ethical and evidence-based policy options;
 providing technical support, catalysing change, and building sustainable institutional capacity;
and
 monitoring the health situation and assessing health trends.
 CRVS (Civil Registration and Vital Statistics) to provide monitoring of vital events (birth, death,
wedding, divorce)

14. It regulates.
1.Communicable diseases ,2. Non-communicable diseases, 3. Environmental health,
4. Life course and life style, 5. Surgery and trauma care, 6. Emergency work,
7. Health policy, 8. Governance and support, 9. Public health education and action,
10. Data handling and publications.
7. ministry of health, labour and welfare (MHLW)
The Ministry of Health, Labour and Welfare (厚生労働省 Kōsei-rōdō-shō) is a cabinet level ministry
of the Japanese government. It is commonly known as Kōrō-shō (厚労省) in Japan. The ministry
provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug
regulations, standards for foods, food additives, etc.
It was formed with the merger of the former Ministry of Health and Welfare or Kōsei-shō (厚生省) and
the Ministry of Labour or Rōdō-shō (労働省).
The Minister of Health, Labour and Welfare is a member of the Cabinet and is chosen by the Prime
Minister, typically from among members of the Diet.
Organization
The ministry contains the following sections as of 2019:[1]
 The Minister's Secretariat (including the Statistics and Information Department)
 The Health Policy Bureau
 The Health Service Bureau
 Pharmaceutical and Food Safety Bureau (including the Food Safety Department)
 The Labor Standards Bureau (including the Industrial Safety and Health Department,
Workers Compensation Department, and Workers' Life Department)
 The Employment Security Bureau (including the Employment Measures for the Elderly
and Persons with Disabilities Department)
 The Human Resources Development Bureau
 The Equal Employment, Children and Families Bureau

15.  The Social Welfare and War Victims' Relief Bureau (including the Department of Health
and Welfare for People with Disabilities)
 The Health and Welfare Bureau for the Elderly
 The Health Insurance Bureau
 The Pension Bureau
 The Director-General for Policy Planning and Evaluation
 Affiliated research institutions (6 research institutes, 218 national hospitals, 13 quarantine
stations, and 3 Social Welfare Facilities)
 Councils (Social Security Council, Health Sciences Council, Labour Policy Council,
Medical Ethics Council, Pharmaceutical Affairs and Food Sanitation Council, Evaluation
Committee for Independent Administrative institutions, Central Minimum Wages
Council, Labour Insurance Appeal Committee, Central Social Insurance Medical
Council, Examination Committee of Social Insurance, Examination Committee for
Certification of Sickness and Disability, Examination Committee for Relief Assistances)
 Regional Bureaus (8 Regional Bureaus of Health and Welfare and 47 Prefectural Labour
Bureaus)
 External Bureaus (Japan Pension Service, Central Labor Relations Commission)
Guideline for Application for Establishment and Revision
of Maximum Residue Limits for Agricultural Chemicals
used outside Japan
I
.
Purpose
This guideline outlines the procedures required to apply for the establishment and revision of
maximum residue limits (MRLs) for agricultural chemicals on/in foods, and the scope of required
documents. The guideline targets agricultural chemicals - pesticides, veterinary drugs, and feed
additives - that are approved in the foreign countries for foods exported to Japan. The foods include
agricultural products, animal products, or seafood.
The requirements given in this document notwithstanding, it is not necessarily appropriate to require
a uniform set of documents for every chemical. Also, advances in science and technology may bring
new analytical and evaluation methods. Therefore, the study results and related documents given in
the guideline can be replaced by other documents sufficient to conduct evaluation for establishment
and revision of MRLs.

18. Thank you…