[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