Accestra Consulting

China NMPA Issues New Regulations on Designating Domestic Agents for Overseas Drug MAH Compliance

Accestra — Mon, 18 Nov 2024 03:50:17 +0000

November 14, 2024

The National Medical Products Administration (NMPA) has officially released the Interim Provisions on the Management of Domestic Agents Designated by Overseas Marketing Authorization Holders (MAH) of Drugs, with new regulations effective from July 1, 2025. These measures are set to strengthen the oversight of overseas MAHs by mandating the appointment of a designated domestic agent within China to manage post-market responsibilities. This announcement is significant for overseas pharmaceutical companies aiming to bring their products into the Chinese market.

As a leading regulatory affairs consulting firm, Accestra Consulting offers comprehensive support to help overseas drug manufacturers comply with this new regulatory requirement. Our services ensure seamless coordination with NMPA standards, aiding in designating qualified domestic agents and navigating the application process through the updated NMPA drug business application system.

Key Points of the New NMPA Regulations:

Effective Date:
- The new regulations will be enforced starting July 1, 2025, allowing overseas MAHs ample time to designate compliant Chinese agents and prepare for the changes.
Chinese Agent Requirements:
According to the new interim provisions, designated Chinese agents must:
- Be a legally established corporate entity in China.
- Possess a robust quality management system suitable for fulfilling MAH obligations.
- Have a dedicated team for drug quality management.
- Maintain an appropriate physical office in China.
Compliance Responsibilities:
The designated Chinese agent will be responsible for various post-market duties, including:
- Ensuring drug quality and risk control, establishing a post-marketing quality assurance systems.
- Implementing a drug traceability system.
- Managing annual reporting requirements and post-marketing variations.
- Establishing pharmacovigilance system and adverse reaction monitoring.
- Handling recalls, random sampling, overseas onsite inspection and more.
Reporting and Transparency:
Overseas MAHs must submit the Chinese agent’s authorization documentation to the NMPA before initial drug importation, with the Chinese agent’s details also listed in the product’s drug insert. Additionally, the NMPA will maintain public access to designated Chinese agents’ information.
Assignment of the Designated Agents:
For a single drug marketed in China, an overseas MAH must appoint a single designated agent within China, while the same Chinese agent may be appointed by multiple overseas MAHs and for different imported drugs.

How Accestra Consulting Can Assist

Navigating the complexities of Chinese pharmaceutical regulations can be challenging, especially with the recent updates introduced by the NMPA. Accestra Consulting specializes in regulatory affairs for the pharmaceutical industry, providing expert guidance on compliance, documentation, and application processes. Our services include:

Chinese Agent Management System Compliance Audit and Consultation:: Support for overseas MAHs in conducting compliance audits of designated Chinese agents or providing consultation services for establishing a compliant Chinese agent management system in accordance with NMPA requirements.
Documentation and Reporting Support:Assisting with documentation preparation and submission, including annual reports, traceability systems, and adverse event monitoring.
Regulatory Strategy Consultation:Tailored strategies to ensure that your pharmaceutical products meet all regulatory requirements for a successful market entry in China.
Chinese Agent Appointment and Compliance:Acting as your designated Chinese agent in China, fully compliant with NMPA standards, and equipped to fulfill all required post-market responsibilities.

With Accestra Consulting as your trusted partner, overseas MAHs can focus on market expansion while we manage the regulatory details. Our team of experts ensures that each step aligns with NMPA’s requirements, from initial documentation to ongoing post-market obligations.

Contact Us

To learn more about how we can support your compliance with the new NMPA regulations, contact Accestra Consulting today. With our expertise in regulatory affairs and Chinese market entry, we streamline the process of designating a Chinese agent and ensure that your business is fully compliant with NMPA’s latest requirements.

Reach out to us at email info@accestra.com for more information.

Source:

https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20241114172951120.html

CPHI Milan 2024: Accestra to Present Building a Successful DMF Application Strategy for Packaging Material Registration in China

Accestra Marketing Team — Tue, 24 Sep 2024 05:15:27 +0000

Time and Location:

8-10 October 2024

Fiera Milano

28, Strada Statale Sempione, 20017, Rho, Lombardia, Italy

INTRODUCTION

CPHI is where the global pharma community comes together to foster connections and ignite partnerships. We’re excited to announce that April Wang, Regulatory Affairs Manager at Accestra Consulting, will be presenting at this prestigious event. She will offer valuable insights on China DMF registration strategies for packaging materials, sharing her expertise with attendees.

Presentation: Building a Successful DMF Application Strategy for Packaging Material Registration in China

Time: Wednesday, 9 October 2024 12:05 PM to 12:30 PM (CET)

Location: Hall 20 – 20C33

key takeaways

China’s DMF Regulatory Framework & Reform
China DMF Registration Pathways & Strategies
Registration Procedures, Timeline & Costs
Dossier Requirements & Checklist
Technical Requirements: Key Considerations
Technical Requirements: Pitfalls & Tips

Speaker:

April Wang

Senior Regulatory Affairs Manager

Accestra Consulting

About me

April possesses an in-depth understanding of Chinese pharmaceutical regulations and has accumulated extensive hands-on experience with China DMF filings and regulatory consulting projects. Her expertise is backed by her strong communication network with key Chinese authorities, including the NMPA and CDE.

Throughout her career, Ms. Wang has successfully supported numerous international pharmaceutical companies, both large and small, in their efforts to enter the Chinese market.

Discover more about the presentation by clicking the link below:

https://visitor.cphieventplanner.com/event/cphimilan2024/planning/UGxhbm5pbmdfMjA0OTc2OQ==

China DMF Filing Webinar

Accestra Marketing Team — Tue, 24 Sep 2024 04:06:43 +0000

Accestra Webinars

In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 24 October 2024.

Mastering Registration of Drug Master File (DMF) in China
for APIs, Excipients & Packaging Materials

Are you navigating the complexities of Drug Master File (DMF) registration in China? Join us for an exclusive webinar where we’ll dive into the essential strategies and regulatory pathways to ensure a successful DMF submission.

Key Topics Covered:

China DMF Regulatory Framework – Gain a comprehensive understanding of China’s evolving regulatory landscape.
China DMF Pathways – Learn the critical steps for streamlining your submission process.
Comparison of Global DMF Standards – See how China’s DMF process compares to the US DMF, EU CEP, and ASMF.
Timelines and Requirements – Get a clear roadmap of what to expect in terms of documentation and timing.
Tips & Pitfalls – Hear expert advice on common challenges and how to avoid costly delays.

Who Should Attend:

This webinar is designed for regulatory affairs professionals, pharmaceutical companies, and international businesses involved in China DMF registration or looking to expand into the Chinese market.

Date:

24 April 2024, Thursday

Time:
15:00 – 16:00 China/Singapore/Malaysia

17:00 – 18:00 Sydney

05:00 – 06:00 EST

09:00 – 10:00 CET

03:00 – 04:00 EDT

Don’t miss this opportunity to enhance your knowledge and stay ahead in the competitive pharma industry!

SPEAKER:

Raymond Ng

Senior Regulatory Affairs Manager at Accestra Consulting

See you there!

– Accestra Events Team

Pharmacovigilance in China Webinar

Accestra Marketing Team — Mon, 23 Sep 2024 10:51:14 +0000

Accestra Webinars

In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 29 October 2024.

Pharmacovigilance in China

Stay informed on the latest developments in Pharmacovigilance (PV) in China. Join us for this insightful webinar, where industry experts will provide a detailed overview of China’s evolving PV landscape and the key strategies for maintaining compliance.

Topics Include:

China PV Framework – Understand the fundamentals of the Chinese Pharmacovigilance system.
Updates on China’s GVP Policies – Stay up-to-date on recent changes to Good Vigilance Practice (GVP) regulations.
China’s GVP Requirements – Learn the specific obligations for pharmaceutical companies operating in China.
Best Practices for Compliance – Get actionable insights on how to ensure compliance with GVP requirements and prepare for inspections by Chinese authorities.
Tips & Pitfalls – Avoid common mistakes and challenges faced by industry peers.
Q&A Session – Have your questions answered by experts in the field.

Who Should Attend:

Regulatory affairs, pharmacovigilance professionals, and pharmaceutical companies with operations or interest in the Chinese market.

Date:
29 October 2024, Tuesday

Time:
15:00 – 16:00 China/Singapore/Malaysia

17:00 – 18:00 Sydney

05:00 – 06:00 EST

09:00 – 10:00 CET

03:00 – 04:00 EDT

Don’t miss this chance to gain valuable insights into China’s PV regulations and stay ahead of compliance requirements.

SPEAKER:

Marylene Zhan

PV Manager at Accestra Consulting

See you there!

– Accestra Events Team

CPHI North America 2024: Accestra to Present China Drug Master File (DMF) Comparing with U.S. and EU

Accestra Marketing Team — Mon, 29 Apr 2024 07:10:09 +0000

Time and Location:
07 – 09 May 2024 |Pennsylvania Convention Center, Philadelphia

INTRODUCTION

CPHI creates connections and inspires partnerships across the global pharma community. Access endless opportunity to grow your business and expand your network at the heart of Pharma!

We’re thrilled to announce that our Senior Regulatory Affairs Raymond Ng will take the stage to present Accestra Consulting. He will share valuable insights and expertise on the topics of China Drug Master File (DMF) Comparing with U.S. and EU.
Presentation:China Drug Master File (DMF) Comparing with U.S. and EU

May 7th 2024, 15:00-15:25 (EST)

Key Takeaway Points

China DMF regulatory framework & reform
China DMF registration pathways & requirements
Registration procedures, timeline & costs
Comparison of China DMF with U.S. & EU
Technical requirements: pitfalls & tips

Presenter:

Raymond Ng,Accestra Consulting Company Senior Regulatory Affairs Manager

raymond@accestra.com

Mr. Ng is based in China with almost a decade of regulatory affairs experience for Chinese market with a master’s degree from the University of Nottingham.
He has extensive knowledge of Chinese pharmaceutical regulatory requirements and has worked on numerous regulatory submissions with Health Authorities.
Mr. Ng has strong communication and practical experience dealing with the Chinese health authorities including NMPA (formerly CFDA) and CDE.
A successful track record of supporting top 50 pharma companies as well as biotech and medtech with market entry into China.

See you there!
– Accestra Events Team

RAPS Euro Convergence 2024: Accestra to Present Exploring Regulatory Pathways for Drug Registration in China: Strategic Approaches

Accestra Marketing Team — Mon, 29 Apr 2024 06:35:16 +0000

Time and Location:
6-8 May 2024 |Berlin Congress Center Alexanderstraße 11, 10178 Berlin, Germany

INTRODUCTION

RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy.

We’re thrilled to announce that our visionary CEO Helen Ye will take the stage to present Accestra Consulting. She will share valuable insights and expertise on the topics of Strategic Options of Regulatory Pathways for Drug Registration in China.

Presentation: Exploring Regulatory Pathways for Drug Registration in China:Strategic Approaches

7 May 2024, 15:05 – 16:05 (CET)

Key Takeaway Points

Standard drug registration procedures in China
Accelerated review pathways
Special pathways to access China
Registration strategy & tips

Presenter:

April Wang, Regulatory Affairs Manager at Accestra Consulting

april.wang@accestra.com

Ms. Wang is a senior regulatory affairs consultant specializing in the Chinese market with a Double Master’s Degree from Fudan University and Luiss Guido Carli University.
She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with DMF filing & regulatory consulting projects during daily work.
Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
A successful track record with supporting international pharma with market entry into China including big and small pharma

See you there!
– Accestra Events Team

DIA Global Forum for Qualified Persons for Pharmacovigilance (QPPV): Accestra to Present China RPPV/QPPV at DIA Global Forum 2023 in Amsterdam

Accestra — Tue, 24 Oct 2023 05:21:53 +0000

This Forum provides valuable insights into the most pressing issues QPPVs are facing today. This event has limited capacity, register early!

Time and Location:

8 – 9 November 2023 | Amsterdam, Netherlands

Meet us in Amsterdam, engage with our speakers face to face about China QPPV requirements and practices, and get real-time feedback for your questions.

INTRODUCTION

The DIA Global QPPV Forum is a must-attend conference for anyone involved in pharmacovigilance. With a focus squarely on the most critical issues in today’s industry, tackling global QPPV challenges, trends demanding heightened QPPV awareness, and the transformative impact of modern technology. Plus, it will continue the ever-popular ‘QPPV Talks,’ offering quick, inspirational insights drawn from real-world cases.

Expect valuable insights from regulatory authorities and international industry leaders, ensuring this conference addresses the pressing issues that QPPVs face today. Mark your calendar for the ‘Hot Topics’ session, a not-to-be-missed highlight!

Join us at the DIA Global QPPV Forum to network with your peers, gain valuable insights, and stay ahead in this constantly evolving role.

Proudly presented by Accestra, an in-field expert in the pharmaceutical and pharmacovigilance industry, we look forward to sharing our expertise on ‘China QPPV.’ Don’t miss this unparalleled opportunity to elevate your understanding and stay ahead of the curve.

9^th November 2023, 9:00 – 10:30 AM (CET time)

Location: Mercure Hotel Amsterdam City

Address: Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Demystifying China’s RPPV/QPPV Landscape

Regulatory Framework of China Pharmacovigilance
Overview of China RPPV/QPPV
China RPPV vs EU QPPV
Authority Inspection Key Points
Tips and Regulations Overview

SPEAKER

Marylene Zhan, Senior PV Manager at Accestra Consulting

Marylene.zhan@accestra.com

Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs. With a Master’s Degree from the Zhongnan University of Economics and Law. Marylene is a seasoned bilingual and bicultural consultant who specializes in China regulatory compliance and pharmacovigilance services (RA/PV). She has a wealth of knowledge on Chinese Pharmaceutical regulations and in-depth insight into dealing with Chinese market access requirements. Marylene has a rich experience in serving international pharma companies with market entry into China, providing support in the areas of adverse event monitoring and reporting, literature screening, PV agreements, Chinese GVP and local regulations, SOP & PSMF writing, and more.

China Toothpaste: Urgent NMPA Simplified Notification Alert for Marketed Products – Deadline November 30th, 2023

Accestra Marketing Team — Mon, 23 Oct 2023 03:53:12 +0000

Toothpaste brands marketing in China: Don’t miss out on the opportunity to take advantage of the simplified notification procedure with the China NMPA. But be wary – the deadline is swiftly approaching. All toothpaste brands must finalize their simplified notification by December 1st, 2023. If missed, brands may face the risk of delisting and an import ban to China.

The China State Administration of Market Regulation (SAMR) rolled out the “Measures for the Supervision and Administration of Toothpastes” on March 23, 2023. This regulation will be active from December 1, 2023.

In a follow-up to the regulation, the National Medical Products Administration (NMPA) made an announcement on September 25, 2023, titled “Announcement Regarding the Implementation of Toothpaste Regulatory Regulations and Simplification of Filing Dossier Requirements for Marketed Toothpastes (No.124/2023).” This grants existing toothpaste brands in China the privilege to send in a simplified notification before the enforcement of a more stringent management system, in line with the cosmetics regulations. This interim period gives brands a buffer to transition seamlessly to the updated cosmetic standards, which mandate comprehensive testing, safety evaluations, and efficacy assessments.

From October 1, 2023, to November 30, 2023, toothpaste applicant can submit the following simplified information through the filing platform for the filing of already marketed toothpaste products:

Applicant's basic information, including the company name, address, contact information, etc. If production is outsourced, the name, address, and contact information of the actual manufacturer should also be submitted.
Basic product information, including the product name, formula, pictures of product marketed packaging label, etc.
Relevant documents proving that the product has a safe usage history in China, including but not limited to:
1.) Production and ingredient records since the product was marketed
2.) Sales invoices
3.) Customs declaration (imported products)
4.) Inspection reports
5.) Commitment of product safety and authenticity of filing information, etc.

The authority will publish the filing information to public on the official website within 5 workdays after submission.

To ensure compliance, brands must prepare a product filing dossier aligning with the new regulations before December 1, 2025. Depending on the product’s initial launch date, the dossier submission protocol varies.

Brands should also note label requirements. If only label format adjustments are necessary, existing labels can be used during the simplified filing. Nonetheless, a label update is mandatory by July 1, 2024.

Additionally, by December 1, 2025, toothpaste products submitted for simplified filing, except those solely marketed for cleaning, must disclose a summary of the basis for their efficacy claims through the filing platform.

The Bottom Line: This policy streamlines the filing process for toothpaste products with an established safety profile, distinguishing between novel and existing products, and grants brands the needed time to align with cosmetic regulations.

For further insights and filing assistance, reach out at info@accestra.com.

Accestra Will Be Presenting At Webinar “China Drug Master File (Dmf) Comparing With Eu & Us” Hosted By Topra

Accestra Marketing Team — Fri, 08 Sep 2023 04:46:39 +0000

Date:19 September 2023

Time:15:00-16:00 (GMT)
10:00-11:00 (ET)
22:00-23:00 (Beijing Time)

WEBINAR INTRODUCTION

This webinar is about China Drug Master Filing (DMF) comparing with EU and U.S DMF. The presentation provides an overview of the DMF regulatory systems covering Active Pharmaceutical ingredients (API), Excipients & Packaging Materials.

Thanks to the global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF, CEP and Japanese DMF requirements. However, local requirements and gaps in the regulations still exists, and it is important to understand these to minimize risks and issues with China CDE & NMPA.

Key Takeaway Points

China DMF Regulatory Framework & Registration System
DMF Registration Pathways & Strategies
Similarities and Differences between China DMF with EU & US
Tips & Pitfalls
Q&A

Presenter:

April Wang, Regulatory Affairs Manager at Accestra Consulting

Ms. Wang is a senior regulatory affairs consultant supporting pharmaceutical companies with understanding Chinese regulatory requirements.
She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with DMF filing & drug (both biologics and chemical drugs) registration projects during daily work.
Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
A successful track record with supporting international pharma with market entry into China including big and small pharma.

See you there!
– Accestra Events Team

RAPS Convergence 2023: Accestra to Present Strategic options of regulatory pathways for drug registration in China

Accestra Marketing Team — Fri, 08 Sep 2023 04:34:11 +0000

Time and Location:
3 – 5 October 2023 | Palais des Congrès de Montréal 1001 Pl. Jean-Paul-Riopelle Montreal, QC

INTRODUCTION

Presentation: Strategic options of regulatory pathways for drug registration in China

4 October 2023, 14:00 – 15:00 (EDT)

Key Takeaway Points

Overview of drug registration in China
Accelerated review pathways
Special pathways of entering China
Registration strategy & tips

Presenter:

Helen Ye, CEO at Accestra Consulting

helen.ye@accestra.com

Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China.
She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customized solutions to international pharmaceutical companies and government institutions.
She leads the registration team to plan, develop and implement compliance strategy for top pharma clients and with successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices, and others.
Ms. Ye has strong communication network with Chinese authorities (e.g., NMPA and CDE) and industry experts in China.

See you there!
– Accestra Events Team