Procedures for
Animal Drugs from Foreign Enterprises to be Registered in the People¡¯s
Republic of China
(Promulgated by the ministry of Agriculture, People¡¯s Republic of
China on July 11, 1988)
Article 1.
This administrative procedure is done according to the stipulation
in article 26 of ¡°The Animal Drug Administration Regulation of the
People¡¯s Republic of China¡± to strengthen the administrative work
of imported animal drugs.
Article 2.
All foreign enterprises with the intention to sell their animal
drugs to the People¡¯s Republic of China should abide by the stipulations
of this administrative procedure.
Article 3.
Foreign enterprises with the intention to sell their animal drugs
for the first time in the People¡¯s Republic of China should apply
for registration and obtain the ¡°Animal Drug Registration and Import
License¡±.
Article 4.
The Registration Permission Certificate for Importing Animal Drugs
is valid only to the animal drugs and the manufacturing enterprise
stated in the license. The manufacturing enterprise may for registration
through an agent entrusted by them. But a trust deed signed by the
chief executive of the enterprise should be handed in together with
the application form for registration.
Article 5.
Drugs without registration are not allowed to be sold, used, or
advertised in the People¡¯s Republic of China.
Article 6.
The registration of animal drugs falls into the following three
categories:
(¢¡) Those which have already been included in the pharmacopoeia,
animal drugs pharmacopoeia, code of animal drugs and professional
standard of the People¡¯s Republic of China.
(¢¢) Those which have not been included in the pharmacopoeia, animal
drug pharmacopoeia, code of animal drugs and professional standard
of the People¡¯s Republic of China, but have already been included
in the pharmacopoeia, animal drug pharmacopoeia, sub-pharmacopoeia
of feed regulations in other countries;
(¢£) those which have not been included in the pharmacopoeia, animal
drug pharmacopoeia, code of animal drugs and professional standard
of foreign countries but have already been approved by the government
pharmaceutical administrative organs in the manufacturing countries
(or region) for production and sales.
Article 7.
The foreign enterprises applying for animal drug registration should
submit referential information according to the stipulated categories.
Article 8.
Foreign enterprises applying for registration of animal drugs in
category (¢¡) should submit:
(1)An enterprise registration certificate issued by the government
of the country (or region) where the manufacturing enterprise is
located and a certificate certifying the approval of the pharmaceutical
administrative organs for production and sales as well as a certificate
certifying the enterprise is up to the standard of GMP for pharmaceutical
production. The above-mentioned certificates must obtain a notarization
issued by the notarial organ of the country where the enterprise
is located or an attestation issued by the Ministry of Foreign Affairs
(or an organ authorized by the Ministry o Foreign Affairs) of the
country where the enterprise is located and then attested by the
Embassy (or Consulate) of the People¡¯s Republic of China stationed
in the country (or region) where the enterprise is located.
(2) The quality standard and analytical method of the animal drugs:
Those which have been included in the national pharmacopoeia, sub-pharmacopoeia
or feed regulations must indicate its number of edition and year
of publication, and their photocopy should be submitted.
(3) The composition, specification and instructions of the animal
drugs.
(4) Samples (attached with analytical report), standard products
of chemical control sample of the animal drugs. In the case of an
anti-biotic product, its technical product sample must be submitted.
The attached samples to be used for the purpose of re-examining
the quality should be taken from three different lot numbers. The
quantity of sample for each lot should be 3-5 times the amount to
be used for test; while the amount of standard products or chemical
control samples should be 5-10 times the quantity to be used for
test.
Article 9.
Foreign enterprises applying for registration of animal drugs in
category (¢¢) should submit the following information in addition
to certificates, information, samples and standard products stated
in category (¢¡):
(1) Its sources and the method of manufacturing;
(2) The clinical test or the regional test;
(3) Tests for pharmacology and pharmacokinetics;
(4) The toxicological test and the special toxicity tests (including
carcinogenicity, teratology and mutagenicity);
(5) The feeding trials with medicated feed additives and animal
reproduction trials as well as the period without the medicated
feed;
(6) The residual test.
Article 10.
Foreign enterprises applying for registration of animal drugs in
category (¢£) should submit the following information in addition
to the required certificates, information, samples and standard
products stated in categories (¢¡) and (¢¢):
(1) The situation about unfavourable reaction of drugs;
(2) The situation about drug resistance and the anti-biotic resistant
strain test.
(3) The test of the effects on environment (such as toxicity to
plants, fishes and insects as well as environmental pollution).
Article 11.
For biological products applying for registration, the following
specific information should be submitted accordingly for each product
in addition to the required certificates, information and samples,
and standard products stated in category (¢¡):
(1) The standard for raw materials of the product;
(2) The cell origin of the cell-culture vaccine and method of propagation;
(3) The qualitative test of the attenuated vaccine;
(4) Different kinds of inactive regent and adjuvant reagent of the
inactivated vaccine;
(5) The speciality, sensitivity and coincidence rate of the diagnosis
reagent.
The information required is to be determined according to the specific
requirements of different products.
Article 12.
Foreign enterprises applying for animal drug registration should
submit the application to the Ministry of Agriculture of the People¡¯s
Republic of China together with an ¡°Application Form for Registration
of Importing Animal Drugs¡± filled by the foreign enterprises in
two copies and the required certificates according to the categories
specified for applying animal drug registration and technical information
in two copies each with Chinese translation or translated abstract.
The Ministry of Agriculture shall conduct the preliminary appraisal
according to the above-mentioned information.
Article 13.
Upon receipt of the approval from the Ministry of Agriculture after
the preliminary appraisal, the enterprise concerned should submit
samples of animal drugs so as to conduct animal trials in the People¡¯s
Republic of China. The items for trial shall be decided by the Ministry
of Agriculture in accordance with the categories specified in the
application for animal drug registration and the information submitted.
Article 14.
The trials should be conducted in the college or university specialized
in agriculture and animal husbandry, scientific research units or
veterinary institutions under the jurisdiction of the Ministry or
the respective provinces appointed by the Ministry or nominated
by the enterprise concerned with the approval of the Ministry.
Article 15.
The trial programme should be formulated jointly by the applying
enterprise and the trial-conducting unit according to the regulations,
and a contract must be signed between the above-mentioned two parties
on this matter. After the trial-conducting unit reported this matter
to the Ministry of Agriculture and obtained the approval from the
Ministry, then the trial can be conducted. In the meantime, a report
should be sent to the bureau of Agriculture (or Animal Husbandry)
at the province (or autonomous region of municipality) where the
trail shall be conducted for record.
Article 16.
For animal drugs of category (¢¡) applying for registration, generally
no potency trial is needed. In case the type of agent, the way of
medication and adaptability are different from those stipulated
in the pharmacopoeia, animal drug pharmacopoeia, code of animal
drugs and professional standard of the People¡¯s Republic of China,
the potency trial should be conducted.
Article 17.
For animal drugs of categories (¢¢) and (¢£) applying for registration,
potency trials should be conducted. The numbers of animals required
for the trials must not be less than the following required numbers:
(1) For control and therapeutic drug:
Large domestic animals 40 head
Medium domestic animals 60 head
Small domestic animals or
poultry 100 head
Fishes 1,000 fish
Bees 10 cases
Silkworm 10 sheets
(2) For antiparasitic drugs:
Large domestic animals 60 head
Medium domestic animals 100 head
Small domestic animals or
poultry 300 head
Fishes 3,000 fish
Bees 20 cases
Silkworm 20 sheets
(3) For medicated feed additives:
Large domestic animals 100 head
Medium domestic animals 200 head
Small domestic animals or
poultry 500 head
Fishes 5,000 fish
Silkworm 40 sheets
(4) For biological products:
Large domestic animals 200 head
Medium domestic animals 400 head
Small animals or poultry 600 head
Fishes 600 fish
Notes: Large domestic animals refer to cattle, horses, mules, donkeys,
camels etc.; medium domestic refer to pig, sheep and goats, dogs,
deer, musk deer, minks, foxes, otters etc., small domestic animals
refer to rabbits, cats, chickens, ducks, geese, pigeons etc.
Article 18.
For registration of animal drugs of categories (¢¢) and (¢£), if the
applying enterprise could submit the drug potency trial report approved
by the government of the manufacturing country (or region), the
number of animals for conducting the re-examination trials could
be reduced to 50% of the numbers as stipulated in Article 17.
Article 19.
For registration of animal drugs of category (¢£), it will be decided
whether it is necessary to conduct trials o pharmacology, pharmacokinetics,
toxicology, special toxicology and reproduction according to the
information submitted by the applying enterprise.
For registration of antiparasitic drugs and medicated feed additives
of category (¢£), if necessary, toxicological and residual trials
should be conducted according to the information submitted by the
applying enterprise.
Article 20.
For registration of biological products, the items and content of
trials shall be determined
according to the requirements of different manufactured products.
Article 21.
Upon receipt of the consent granted by the Ministry of Agriculture
to accept the registration, the applying enterprise shall provide
the sample, standard samples and chemical control samples of the
animal drugs to the national institute for the control of animal
drugs for quality reexamination. Both sides will decide the analytical
methods and reagent to be used and other matters concerned.
Article 22.
According to the animal trial report, quality reexamination report
and the evaluation report from the Animal Drug Appraisal committee,
the Ministry of Agriculture should evaluate, approve and issue the
¡°Animal Drug Registration and Import License¡±.
Article 23.
The period of validity of the ¡°Animal Drug Registration and Import
License¡± is for five years starting from the date of its approval.
If the applying enterprise has the intention to continue its sales
in China, an application for re-registration should be submitted
to the organ issuing the certificate six months prior to the expiration
of the certificate.
Article 24.
After the Ministry of Agriculture examines and approved the application
for re-registration, the ¡°Animal Drug Registration and Import License¡±
shall then be renewed. No relative certificates and information
shall be submitted and no animal trial and quality reexamination
shall be conducted at the time when renewing the certificate.
Article 25.
Within the period of validity of the ¡°Animal Drug Registration and
Import License¡±, if the manufacturing enterprise has any changes
concerning the raw materials used, the formula and analytical method
of the drugs, the manufacturing enterprise must submit the changes
to the Ministry of Agriculture in time and the relative technical
information materials should be attached.
Article 26.
If there is any damage or less caused by the quality of drugs during
the trial, it should be compensated by the applying enterprise.
Article 27.
The applying enterprise should pay the trial expenses, the analytical
expenses and registration fees as follows:
(1) Registration
One thousand US dollars (US$1,000) should be paid for each variety
of the product; and for the renewal of the ¡°Animal Drug Registration
and Import License¡±, only 50% of the original charges should be
paid. For animal drugs registered before the promulgation of this
procedure, he renewal of the certificate should be paid according
to the fees stipulated in this procedure.
(2) Test fee:
One thousand US dollars (US$1,000) should be paid for each variety
of the product (If a new product of the same variety is to be tested,
an additional charge of two hundred US dollars (US$200) should be
paid for each new product.).
One thousand US dollars (US$1,000) should be paid for a complex
product;
For biological products, US$1,200 to US$5,000 should be paid according
to the specific variety of the product and the items for analysis;
In case the samples are not up to standard, new samples should be
submitted for reexamination, and an additional 50% of the first
test fee should be paid.
For special items, the charges shall be determined separately.
(3)The expenses for potency trial, feeding trial, pharmacological
trial, toxicity trial and residual trial shall be determined according
to the animals required for the trial, and the contents and the
scale of the trial.
Article 28.
For an animal drug which has already acquired the ¡°Animal Drug Registration
and Import License¡±, the respective foreign enterprise should indicate
its certificate number on the outer package as well as in the direction
for utilization of the drug if the said animal drug is to be marked
in the People¡¯s Republic of China.
Article 29.
For an animal drug which has already acquired the ¡°Animal Drug Registration
and Import License¡±, in case it fails to reach the test standard
continuously for two times when imported to China, the Ministry
if Agriculture shall issue a public notification and revoke the
License. Within a period of one year starting from the date of revocation,
no application for registration of the said drug shall be allowed.
Article 30.
If the Ministry of Agriculture deems it necessary to conduct an
inspection of the foreign enterprise which has registered its drug,
the said enterprise should provide all the necessary conditions
for inspection. If the enterprise inspected is not consistent to
the laws and regulations of animal drug administration of the People¡¯s
Republic of China, the ¡°Animal Drug Registration and Import License¡±
acquired shall be revoked or the products of the said manufacturing
enterprise should be rejected to be registered in China.
Article 31.
The ministry of Agriculture shall publish periodically the ¡°Registration
Catalogue of the Imported Animal Drugs¡±.
Article 32.
The animals and animal drugs stipulated in this procedure refer
to the same definition as stipulated in Article 48 of ¡°The Animal
Drug Administration Regulations of the People¡¯s Republic of China¡±.
All the medicated feed additives are included in the administrative
scope of this procedure.
Article 33.
The Ministry of Agriculture of the People¡¯s Republic of China is
responsible for the interpretation and amendment of this procedure.
Article 34.
This procedure shall enter into force from the date of promulgation.
The ¡°Procedures Laid Down by the Ministry of Agriculture, animal
Husbandry and fishery of the People¡¯s Republic of China for Retrial
and Registration of Veterinary Drugs Carried Out by Foreign Companies
in China¡± issued on August 30, 1985 shall be abolished simultaneously.
In case of discrepancy, the original version in Chinese shall prevail
Source: en.ivdc.gov.cn
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