Certification and
EDMF
Comparison of registration
EDMF
and
Cash On Shipment
Certificates are all effective and necessary proof materials for APIs to enter the European market.
Both are used to prove.
Quality documents of API used in preparation products to support the market application of preparation products using this API in Europe.
Please (
The Mathematical Association of America (MAA)
); What's the difference between them?
First of all, there are differences in evaluation methods.
EDMF
It is reviewed by institutions in a single country and listed as a preparation.
Part of the application documents can be reviewed together with the application documents for the marketing license of the whole preparation. Depending on the system
Agent, different evaluation agencies have different emphases,
So there will be different requirements for documents.
Ask different questions. Regardless of the original
The raw materials used to produce which preparation, regardless of
EDMF
Whether it is registered or not, it must be re-evaluated because
For American API manufacturers, it takes more time and energy to apply for registration many times. but
Cash On Shipment
The application documents shall be examined by an expert committee composed of relevant departments.
The results of the review will decide whether to issue it.
Cash On Shipment
Certificate.
Once the API is obtained,
Cash On Shipment
In the 3 1 member countries of the European Pharmacopoeia Commission, certificates can be used for ownership.
Preparation production in pharmaceutical enterprises.
Secondly, the situation is different.
EDMF
As well as the application for the marketing license of the preparation drugs using the API (
The Mathematical Association of America (MAA)
)
It is inseparable and must be applied by European end users who use API; but
Cash On Shipment
Certificates are issued directly to.
Raw material drug manufacturers,
Therefore, it can be independently applied by API manufacturers.
,
No ready-made middlemen and end users are needed.
So manufacturers are more active in the application process.
Third, the scope of application is different.
EDMF
This procedure is applicable to all APIs, as long as they are APIs, regardless of whether they are APIs or not.
Whether it has been listed in the European Pharmacopoeia,
You can pass
EDMF
Enter the European market in the form of documents,
but
Cash On Shipment
Certificates can only handle
Substances already included in the European Pharmacopoeia,
Of course, not only raw materials,
Also comprises auxiliary materials for producing the preparation,
China pharmaceutical excipients
You can also apply.
Cash On Shipment
Certificate.
Fourth, the required information is different. take for example
EDMF
The document must include the stability research data of the drug, and
Cash On Shipment
These materials are not mandatory in the application documents for certificates.
Fifth, the application results are different. apply for
Cash On Shipment
The result of the certificate is to issue the certificate directly to the manufacturer of the API.
Books,
As long as a copy of the certificate is provided to the middlemen or end users in Europe,
The other party can buy ours.
Raw materials, and
EDMF
The result of registration is to tell only one preparation manufacturer.
EDMF
Registration number of the document, Europe
The certification body will not tell the manufacturer of the API this registration number.
Manufacturers of APIs can only buy from.
Check the registration number of European pharmaceutical preparation manufacturers.
cosine
(
certificate
about
suit
) refers to the applicability certification of the European Pharmacopoeia, in order to examine whether the European Pharmacopoeia can
Effectively control the quality of imported drugs,
This is another proof that the end-users in the EU legally use China API.
Book law.
The advantage of this registration method is that it does not depend on the end user.
Applications can be independently completed by API manufacturers.
China's API manufacturers can report to the EU Drug Quality Steering Committee (
EDQM
) Submit the product.
cosine
a certification document
Pieces (
cosine
file
), apply for
cosine
Certificate, at the same time, the manufacturer must promise to carry out strict quality management of product production.
follow
Good operating practices
Standard,
After the document review and possible on-site inspection have passed,
EDQM
Will tell the manufacturers of raw materials and drugs
question
cosine
Certificate.
If the pharmaceutical manufacturers of EU member states as end users are prepared to adopt raw materials produced in China,
As long as you attach the product
cosine
A copy of the certificate can be easily approved.
European Pharmacopoeia Adaptability Certificate (
Circular error probability (circular error probability)
) is not only recognized by all EU member states, but also by many European countries.
Countries with pharmacopoeia status in Europe are recognized, such as many European countries outside the EU, Australia and China.
Circular error probability (circular error probability)
The certificate may
replace
EDMF
This document is used for drug listing application and raw material source change application.
ask
With America,
Coordination between EU and Japan in drug registration procedures and regulations,
Raw materials imported from the EU
Gradually approaching the United States in registration.
United States Food and Drug Administration
Focus on the scene
Good operating practices
The way to check,
It is possible to propose to every family in the future.
Cash On Shipment
admit
The certificate manufacturer conducts on-site inspection.
Good operating practices
Check.
oneself
1999
Since 2000, API manufacturers have been applying.
Cash On Shipment
Certified technical documents must be accompanied by two letters of acceptance.
Nuoxin,
A letter guarantees that the product meets the requirements.
Good operating practices
Standardized production,
Another letter promised to agree to the relevant review by the European Union.
Inspection agencies conduct on-site inspections. If the EU
EDQM
about
Good operating practices
Review is more and more frequent, and even becomes necessary in the end.
An important means of censorship,
Manufacturers should be fully prepared for this and make their own
Good operating practices
The management situation can adapt.
Inspection by the European Union.
European Union
Good operating practices
Please contact China.
Good operating practices
There are the following differences in certification: first, the EU's
Good operating practices
Inspection basis
integrated circuit
H
Q7A
This guide, manufacturers should refer to this guide for their own inspection; Secondly, all quality management documents and operations
Specification (
Standard operating procedure (standard operating procedure)
) and various production management forms, signs, labels and production records should be bilingual and able to
Let foreign censors understand; Third, it is necessary to carry out
Good operating practices
Train all employees to understand and adapt to the characteristics of foreign inspection.
Point.
Cash On Shipment
The certification process is of positive significance to enterprises, which will make enterprises
Good operating practices
Management has reached the international level, and with
With the further development of tripartite coordination between the United States, Europe and Japan, through the EU's
Good operating practices
Check and
Cash On Shipment
Authentication may ultimately be straightforward.
Enter the American and Japanese markets,
At least it will make America
United States Food and Drug Administration
Registration becomes easier.
Therefore,
Although at present
EDQM
still
No right.
Cash On Shipment
All applicants for certification will implement it.
Good operating practices
Inspection, but China's API manufacturers are proposing
Cash On Shipment
admit
At the same time, the certificate application is aimed at the European Union.
Good operating practices
It is worthwhile to make full preparations for the inspection.