How to Secure the First Bucket of Gold in Global Expansion: Secrets Revealed!

According to statistics from the China Chamber of Commerce for Import and Export of Medicines and Health Products, China’s total import and export trade volume of pharmaceutical products in the global market reached USD 97.755 billion in the first half of 2024, a year-on-year decrease of 1.87%. Among this, imports amounted to USD 45.176 billion, down 5.93% year on year; exports totaled USD 52.579 billion, up 1.91% year on year. This indicates that China’s pharmaceutical exports have returned to normalcy in the first half of this year after experiencing significant fluctuations. The performance of specific products and markets is as follows:

1. In the face of such a hyper-competitive domestic market, should we still dive in headfirst only to be overwhelmed by the tide?

2. Based on the above analysis, it is evident that global expansion is a sound strategic choice.

3. In the face of this opportunity, what actions should we take? What knowledge should we acquire?

As is well known, the U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE) have many differing requirements in numerous specialized areas regarding testing standards for drugs and active pharmaceutical ingredients (APIs). As an agency widely recognized by many countries around the world, the FDA has established highly mature and comprehensive drug standards and review mechanisms. Many global pharmaceutical standardization organizations, such as the European Medicines Agency (EMA), the World Health Organization (WHO), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), are aligning their standards with those of the FDA. Given that FDA approval is the sole pathway for entering the U.S. market—the largest pharmaceutical market globally—understanding the FDA’s requirements and approval processes for new drugs and generic drugs holds significant practical and strategic value for pharmaceutical companies. So, what exactly are the differences between the FDA and the CDE?

Take a simple example: regarding instrument requirements for the gel-clot method of bacterial endotoxin testing, the FDA mandates automatic audit trails for methodological aspects of test results. Absence of such automatic audit trails will result in appropriate point deductions during regulatory review scoring. Currently, most bacterial endotoxin gel-clot instruments worldwide rely on manual gel preparation and visual observation for data auditing. Therefore, the ability to meet FDA requirements and secure additional scoring points has become a critical factor in the bacterial endotoxin testing process.

There are many such examples, which will not be listed one by one here.

To align with market changes and trends, stimulate demand among domestic enterprises, and drive business diversification for companies in China,Suzhou Danhuang Technology Co., Ltd., Beijing Chengfeng Jihai Technology Co., Ltd., proposed to inviteXi'an Pharmaceutical Association, atEarly March 2025, inXi'an CityCo-organized by【Training on Quality Control and Testing Standards for Exporting Finished Pharmaceutical Products and Active Pharmaceutical Ingredients】At that time, authoritative experts and enterprises well-versed in domestic and international requirements for drug research and development, testing, and regulatory submissions will be specially invited to share their extensive experience and case studies accumulated over the years. The relevant information regarding the upcoming [Training on Quality Control and Testing Standards for Formulations and Active Pharmaceutical Ingredients in Global Markets] is hereby announced as follows:

Training Time:March 11–12, 2025

Location:Xi'an Hotel, 2nd Floor, Yannian Pavilion

Organizer:Xi'an Pharmaceutical Association

Organizer:Suzhou Danhuang Technology Co., Ltd., Beijing Chengfeng Jihai Technology Co., Ltd.

This training session will center on the theme of “Quality Control and Testing Standards for Finished Dosage Forms and Active Pharmaceutical Ingredients in Overseas Markets,” featuring multiple topics such as a comparison of FDA and CE pharmacopoeial testing standards, compliance issues during the drug development phase, and analytical methods for endotoxin testing in exported finished dosage forms. Attendees will not only have the opportunity to hear insightful presentations from distinguished guests but also participate in roundtable discussions for face-to-face exchanges with experts.

In addition, the training willIn Combination with Practical Applications, arrangePractical Demonstration of Laboratory Drug Testing and Pharmaceutical Analysis Instruments, helping enterprises master testing standards and applications to enhance their product quality control capabilities.

Agenda:

*Agenda updated as of December 26; subject to change based on actual attendance.

Training Fees:RMB 2,480

Cost Benefits:

（1）【Training on Quality Control and Testing Standards for Overseas Export of Drug Products and Active Pharmaceutical Ingredients】One Ticket

（2）One lunch provided for the two-day training

(3) One ticket for the dinner networking event on the first day of training (March 11)

（4）An invoice for conference fees will be issued upon completion of the training. (For special circumstances regarding the invoice, please communicate and clarify with the registration contact person of the organizer in advance.)

（5）During the Training Period 2-Day Hotel Corporate Rate Booking ( 3 Month 10-day admission, 3 Month Check out on the 12th)

Registration Contact:Suzhou Danhuang Technology Co., Ltd.: Ying Erjia 13439390341 (WeChat available)

Remittance Information: 

Company Name: Suzhou Danhuang Technology Co., Ltd.

Beneficiary Bank: China Merchants Bank Co., Ltd., Suzhou Dushu Lake Sub-branchAccount Number: 512911997810301

Contact: Ying Erjia

Tel: 13439390341

E-Mail：ying.ej@vcbeat.net  

Other Matters:

(1) Registration

1）Registration Time: 2025 Year 3 Month 10th 14:00 Start

2）Registration Venue: Xi'an Hotel, Xi'an City, Shaanxi Province 1 Floor Lobby Registration Desk

3）Registration Address: Chang'an North Road, Beilin District, Xi'an City 58 No.

(2) Accommodation

1) Contractual Price

a. Standard Twin Room: RMB 280 per room per night, including breakfast for two

b. Standard Room with Double Bed: 280 CNY/room/night, including breakfast for two

2) Reservation Hotline

a. Contact: Manager Yan Ping

b. Contact Information: 18991309763

c. Note: Please inform Manager Yan that I am a participant in the March 11 [Training on Overseas Expansion for Formulations and Active Pharmaceutical Ingredients].

d. Note: As our company is unable to issue a special VAT invoice for accommodation, please settle the accommodation fees and handle invoicing directly with the hotel.

(3) Food and Beverage

1) Hotel accommodation includes breakfast for two days

2) The organizer will arrange lunch (buffet) for the two-day conference and the appreciation dinner on the 11th for you.

3) Other meals are at your own expense.

(4) Transportation

1) Xi'an Xianyang International Airport Line

a. Distance: 49 km

b. Airport Shuttle Bus: Take the Xi’an Hotel line of the airport shuttle bus for direct access to the main entrance; fare is 25 yuan per person.

2) Xi'an Railway Station Line

a. Distance: 4 km

b. Taxi: approximately RMB 20

3) Xi'an North Station Line

a. Distance: 22 km

b. Taxi: approximately RMB 60

(5) Parking

1) Parking fee: RMB 5/hour, with a daily cap of RMB 30

2) Number of parking spaces: 200 private compact car parking spaces (surface parking lot + multi-story parking garage)

Scan the QR code below to register.

Please contact: Ying Erjia

Tel: 13439390341 (also WeChat)

E-Mail：ying.ej@vcbeat.net

Below is the notice from the Xi'an Pharmaceutical Association granting approval for this event, hereby released!