[Federal Register Volume 59, Number 171 (Tuesday, September 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21788]
[[Page Unknown]]
[Federal Register: September 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA 225-94-8001]
Memorandum of Understanding Concerning Cooperation and
Information Exchange on Drugs and Biological Products Facilitating
Importation Between the Food and Drug Administration and the Russian
Federation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the Russian
Federation. The purpose of the MOU is to exchange information on drugs
and biological products and to facilitate the development of the
Russian health care sector by establishing in Russia a streamlined
registration procedure for U.S. drugs and biological products.
DATES: The MOU became effective February 15, 1994.
FOR FURTHER INFORMATION CONTACT: Phil Budashewitz, Office of Health
Affairs (HFY-50), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-4480.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and memoranda of understanding
between FDA and others shall be published in the Federal Register, the
agency is publishing notice of this memorandum of understanding.
Dated: August 26, 1994.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
Memorandum of Understanding Between the Food and Drug Administration,
Public Health Service, Department of Health and Human Services of the
United States of America and the Ministry of Health and Medical
Industry and the State Committee For Sanitary and Epidemiological
Surveillance of the Russian Federation Concerning Cooperation and
Information Exchange on Drugs and Biological Products Facilitating
Importation
The Food and Drug Administration (FDA) of the United States
(U.S.), on the one hand, and the Ministry of Health and Medical
Industry and the State Committee for Sanitary and Epidemiological
Surveillance of the Russian Federation, on the other hand,
hereinafter referred to as the participants,
Building upon the foundation laid by the Memorandum of Understanding
signed at Moscow September 23, 1993 under the auspices of the U.S.-
Russia Business Development Committee's Subgroup on Medical
Equipment, Pharmaceuticals, and Health Services, and in accordance
with the Agreement on Cooperation in the Fields of Public Health and
Biomedical Research signed on January 14, 1994 by the Government of
the United States of America and the Government of the Russian
Federation,
Strengthening the bonds of friendship among the participants,
Have reached the following understanding to guide their cooperation:
I.
The goals of the participants in entering into this Memorandum of
Understanding are to:
1. Exchange information on drugs and biological products and on
requirements applicable to them (including standardization,
registration, quality control, and product side effects), including
prompt exchange of information on removal of drugs and biological
products from the market or restrictions on their use.
2. Facilitate the development of the Russian health care sector
by establishing in Russia a streamlined registration procedure for
U.S. drugs and biological products that are produced in the United
States and that FDA permits to be freely marketed in the United
States (see Annex). The Russian Federation participants will use
this streamlined procedure for such United States products.
This Memorandum of Understanding provides the procedures needed to
implement the agreement in the earlier Memorandum of Understanding,
signed on September 23, 1993, that it would be mutually beneficial
for the participants to work together to streamline the process for
registering and certifying U.S. drugs and biological products for
importation into the Russian Federation when these products are
permitted by FDA to be freely marketed in the United States. The
effect of the participants' joint endeavors under this Memorandum of
Understanding will be to extend to Russian users access to U.S.
drugs and biological products of the same safety, effectiveness, and
quality available to U.S. users of such products.
II.
This Memorandum of Understanding covers drugs and biological
products that are produced in the United States and that are
permitted by FDA to be freely marketed in the United States
including:
1. Drugs: articles that meet the definition of a drug under the
U.S. Federal Food, Drug and Cosmetic Act. This Memorandum of
Understanding does not apply to homeopathic drugs.
2. Biological products: products that are regulated as
biological products under the U.S. Public Health Service Act.
III.
1. The Russian Federation participants will streamline their
registration requirements of those U.S. drugs and biological
products that are produced in the United States and that are
permitted by FDA to be freely marketed in the United States.
2. For drugs and biological products that are produced in the
United States and that FDA permits to be freely marketed in the
United States, the Russian Federation participants will accept FDA's
decisions and regulations on premarket approval, licensing,
monographs, and related matters, as well as FDA's product quality
standards and enforcement of manufacturing controls and other
requirements.
3. All products that can be defined as a controlled substance or
highly addictive can be registered in the Russian Federation only
after receiving the approval of the Russian Federation's State
Committee on Controlled Substances. Products for which this approval
will be necessary will be further explained in an exchange of
letters between the participants.
4. This Memorandum of Understanding sets forth, in an Annex, the
information that United States firms will have to submit to the
appropriate Russian Federation participant concerning drugs and
biological products subject to this Memorandum of Understanding,
produced in the United States, and permitted by FDA to be freely
marketed in the United States, to obtain permission for these
products to be freely marketed in the Russian Federation. Where the
necessary information listed in the Annex is submitted, the Russian
Federation participants will not require, as a condition of
importation, the conduct of any additional clinical or analytical
review or testing. Registration shall take no more than 90 days
after the submission to the appropriate Russian Federation
participant of the information required in the Annex and any fee
required by the Russian Federation. At the time of the request for
registration of vaccines and sera, the Russian Federation has the
right to require additional documents which will satisfy the Russian
Federation's requirements. Cases in which additional documentation
will be necessary will be further explained in an exchange of
letters between the participants.
5. Upon request of the Russian Federation participants, FDA will
provide access to information on the compliance status of drugs and
biological products and manufacturers that are eligible for Russian
Federation registration under this Memorandum of Understanding to
the extent that the information disclosure is in accordance with
U.S. law. FDA also will respond to inquiries from the Russian
Federation participants about information submitted under the Annex
with respect to such matters as the marketing status of any drug or
biological products. The participants will share information about
any drug or biological product that presents a significant risk to
users.
6. Under this Memorandum of Understanding, the participants will
share expertise and provide assistance and information to one
another when necessary, subject to the availability of funds. Upon
request of FDA, the Russian Federation participants will treat as
confidential any information provided to it by FDA that is not
public information. Upon request of a Russian Federation
participant, FDA will likewise respect the confidentiality of
information that the Russian Federation participant provides to FDA,
to the extent permitted by law.
7. FDA will provide the Russian Federation participants with up-
to-date copies of the laws, regulations, guidelines, and procedures
used to help ensure that drugs and biological products are of a
level of quality sufficient for the protection of the public health.
The Russian Federation participants will provide FDA with up-to-date
copies of laws, regulations, guidelines, and procedures concerning
the registration of these products imported into the Russian
Federation from foreign countries in general and from the United
States in particular.
8. The participants will meet periodically to consult with each
other in order to promote cooperation and to facilitate the
implementation of this Memorandum of Understanding. As the need
arises, the participants will develop and agree on specific plans of
cooperation.
9. The participants may establish a coordinating committee and
one or more technical committees composed of representatives of each
participant with expertise in regulation of drugs and biological
products, to assist in the implementation of the Memorandum of
Understanding.
10. The participants will enter into, within six months of the
effective date of this Memorandum of Understanding, additional
Memoranda of Understanding concerning certain foods and medical
devices imported into the Russian Federation from the United States.
IV.
The following offices are designated as liaison offices for the
participants:
A. For FDA:
Special Programs Officer, International Affairs Staff, Office of
Health Affairs (HFY-50), (currently Philip M. Budashewitz), Food and
Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857,
U.S.A.
B. For the Russian Ministry of Health and Medical Industry:
Dr. Alexander I. Machula, Director, Department of the State
Committee on Quality Control of Drugs and Medical Devices,
Rakhmanovsky per., 3, Moscow, 101431, Russia
C. For the Russian State Committee for Sanitary and Epidemiological
Surveillance:
Dr. Anatoly A. Monisov, Deputy Chairman, Vadkovskiy per. 18/20,
Moscow, 101474, Russia
This Memorandum of Understanding will enter into force for three
years effective upon signature of all participants. It may be
extended or amended by mutual written consent. It may be terminated
by any participant by a 60-day advance written notice to the other
participants.
This Memorandum of Understanding is done in the English and Russian
languages, each text being equally authentic.
For the Food and Drug Administration of the United States of America:
By: David A. Kessler, M.D.
Commissioner of Foods and Drugs
Date: January 28, 1994.
By: Mary K. Pendergast
Deputy Commissioner/Senior Advisor to the Commissioner
Date: January 28, 1994.
For the Russian Participants:
By: Dr. Eduard A. Nechayev
Minister of Health and Medical Industry of the Russian Federation
Date: February 15, 1994.
By: Dr. Eugeni N. Beliaev
Chairman, State Committee for Sanitary and Epidemiological
Surveillance of the Russian Federation
Date: February 15, 1994.
By: Dr. V. M. Cherepov
Co-Chairman of the Subgroup on Medical Equipment, Pharmaceuticals
and Health Services of the Russian-United States Business
Development Committee
Date: January 28, 1994.
Annex
The Necessary Information to be Submitted by a U.S. Company to the
Russian Federation Authorities for Registration in the Russian
Federation of Drugs and Biological Products Which are Produced in the
United States and Permitted by the United States Food and Drug
Administration (FDA) to be Freely Marketed in the United States
1. The firm will submit a letter stating:
a. Name of firm
b. Address
c. Telephone and facsimile number
d. Name, title and signature of firm's authorized responsible
representative
e. That the drug or biological product has been produced in the
U.S.
2. The firm will provide a copy of the letter that FDA has sent to
the firm indicating that the product may be legally marketed in the
United States.
3. The firm will provide a copy and Russian translation of the FDA
approved product package insert (information and instruction sheet)
containing but not limited to the following information:
a. Name: trade, generic, and chemical
b. Description: chemical and pharmacological class
c. Clinical pharmacology/mechanism of action
d. Indications and usage information
e. Contraindications
f. Warnings
g. Precautions
h. Adverse reactions and information on toxicities
i. Information on overdose
j. Dosage and routes of administration
k. How the medical product is supplied, including dosage form
and strength
l. Product usage/preparation and storage information
m. Other information as listed in product package insert.
4. The firm will provide a copy of U.S. Pharmacopeia Official
Monograph (article), if appropriate.
5. The firm's authorized responsible representative will sign and
submit a statement that the firm is in compliance with FDA's Current
Good Manufacturing Practice (GMP) regulations.
6. The firm will provide a copy of the most recent FD-483, FDA
Notice of Inspectional Observations that is relevant to the drug or
biological product for which registration is sought.
7. The firm's authorized responsible representative will sign and
submit a statement that all information submitted is truthful,
accurate and complete.
8. The firm will submit information on any changes in the above
information within 30 days of any change in any of the information
referred to in paragraphs 1-5, including any FDA-approved changes in
the package insert referred to in paragraph 3.
9. The firm will provide samples of the product in the packaged
form in which it is offered for registration.
[FR Doc. 94-21788 Filed 9-2-94; 8:45 am]
BILLING CODE 4160-01-F
