WHO GMP Compliance

I、Project introduction

The World Health Organization (WHO) Supplier Pre-qualification (WHO Pre-qualification, PQ-certified) is a United Nations action plan launched in 2001 to expand access to selected priority drugs, with the goal of ensuring international funds (such as the Global Fund GFTAM, The United Nations Assistance International Drug Purchase Facility (UNITAID) procured the quality, efficacy and safety of medicines to serve patients in developing countries.

The WHO has developed a list of drugs that meet the proposed standards to qualify for production certification, allowing drug purchasers to purchase from this list. Therefore, the general application for “WHO PQ certification” generally focuses on these drugs, mainly for the treatment of urgently needed drugs such as anti-HIV/AIDS drugs, malaria drugs, tuberculosis drugs, reproductive health drugs, influenza drugs, acute diarrhea. Drugs and neglected tropical disease drugs, in addition, some anti-cancer drugs are also very popular.

“WHO PQ Certification” is not limited to preparations, but is also applicable to APIs.

1. Huge market opportunities

According to WHO statistics, the market for antiretroviral drugs reached US$1.5 billion in 2012. By the end of 2012, about 10 million patients had received antiretroviral treatment. In fact, the number of patients requiring treatment has reached 29 million. Far from meeting the real needs.

In the treatment of malaria diseases, the current market size of antimalarial drugs has reached 300 million US dollars. With the phasing out of old ineffective therapies, more and more patients are beginning to receive the first-line treatment recommended by the World Health Organization, with artemisinin as The basic combination therapy is expected to grow steadily.

In terms of tubercle bacilli, the total market size of low- and middle-income countries is 730 million US dollars, and the donation market is expected to be 200 million US dollars, including 80 million US dollars of first-line anti-tuberculosis drugs and about 120 million US dollars of second-line anti-tuberculosis drugs. Experts predict that the first-line drugs in the future The market will remain stable, and with the improvement of drug-resistant tuberculosis detection technology, the second-line drug market will continue to expand.

The huge market has unlimited opportunities, and you can share this big cake by “WHO PQ certification” and entering the procurement catalog.

2. What are the benefits of Chinese enterprises passing the “WHO PQ Certification”?

(1) “WHO PQ Certification” is independent of the registration of the State Food and Drug Administration (CFDA), and can be developed from the bulk drug to the formulation certification, and free technical support provided by the WHO can also be obtained during the certification process.

(2) “WHO PQ Certification” is publicly recognized in many countries around the world. Once the “WHO PQ Certification” is passed, it is beneficial to register in many importing countries, and can also obtain confirmations in line with international GMP requirements, reducing the an examination.

(3) Obtaining “WHO PQ Certification” can enter the international procurement bidding, and it is also conducive to improving the position of the enterprise in the domestic market.

3. How to pre-certify through WHO?

“WHO PQ Certification” can be achieved in two ways:

The first way is to publish the invitation letter of intent - submit the drug that has not been approved by SRA - submit the drug declaration information and production site documents - WHO conducts comprehensive review and on-site inspection - meets the requirements - passes the certification;

The second way is to publish the invitation letter of intent - the drug approved by the SRA - for the original drug and generic drug - SRA registration (combination confirmation SRA approval) - simplified review - acceptable - through certification.

Ⅱ、the service content

1. Assist in product determination;

2. Develop certification project plans and strategies;

3. Liaise with WHO;

4. Production submission "Application for Certification Willingness (EOI)"

5. Preparation of API (API) application documents;

6. Preparation of preparation (FPP) application documents;

7. Make a complete application;

8. Submit a certification application;

9. Track the review process;

10. Coordinated samples are submitted for inspection;

11.GMP compliance preparation and inspection

12. Certificate application and follow-up tracking

13. CMC R&D, BE research and possible safety review studies

Ⅲ、our advantage

1. Long-term rich international drug registration and GMP compliance inspection experience;

2. Long-term experience in Chinese preparation, especially import registration;

3. Established a working team with international preparation registration and rich GMP experience;

4. Standard professional workflows and working standards that have been formed;

5. Years of international registration and GMP compliance with regulations and technical requirements for special research and close tracking;

6. The ongoing European registration of injection needles, EPO, vaccines, etc., and GMP compliance with project accumulation experience;

7. Support from professional international consulting company partners.