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Value of Malaysia PIC/S GMP Certification

Published on 03.05

New Opportunity for Chinese Pharmaceutical Companies Going Global: The Core Value of Malaysia PIC/S GMP Certification

On September 24, 2021, China's National Medical Products Administration officially launched the pre-accession application process for the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This move will not only accelerate the internationalization process of China's drug regulatory system and effectively ensure public safety and health rights in medication use, but also comprehensively enhance the quality management efficiency in the domestic pharmaceutical manufacturing sector, assisting the pharmaceutical industry in deeply integrating into the global market.

Drug regulatory and inspection agencies in various regions, as the core responsible entities for ensuring national medication safety and preventing drug safety risks, face new challenges in the context of globalization. With the continuous expansion of cross-border drug circulation, the correlation and complexity of cross-regional drug safety risks have significantly increased. This requires regulatory agencies worldwide to strengthen collaborative efforts to jointly address various emergent drug safety issues arising from globalization. As a professional and authoritative international organization, PIC/S shoulders indispensable key functions in this collaborative system.

I. Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PIC/S (full English name: The Pharmaceutical Inspection Co-operation Scheme) has multiple translations in domestic literature, such as the International Pharmaceutical Certification Cooperation Organization, International Pharmaceutical Inspection Cooperation Plan, and International Pharmaceutical Inspection Organization. Its predecessor can be traced back to the Pharmaceutical Inspection Convention (PIC) initiated by the European Free Trade Association in 1970. This convention was jointly signed and initiated by 10 member countries of the European Free Trade Association, including the United Kingdom and Portugal, and it was a non-governmental international organization.

However, in accordance with the relevant legal requirements of the European Union, EU member states are not permitted to conclude treaties with non-EU countries outside of the EU level. For this reason, in 1995, the relevant parties established a more broadly scoped and flexibly operated informal cooperation mechanism, namely the Pharmaceutical Inspection Co-operation Scheme (PIC/S), to replace the legal treaty arrangements under the PIC framework. As the only international cooperative organization globally composed of regulatory agencies from various countries with GMP inspection authority, the Good Manufacturing Practice (GMP) standards formulated by PIC/S since its establishment have gradually evolved into international general guidelines and the core benchmark in the field of international GMP inspections.

1. Main differences between PIC/S and PIC

Currently, its members cover drug regulatory agencies from over 50 countries worldwide. Regulatory departments of major developed countries are included. The drug regulatory departments of Taiwan and Hong Kong, China, joined PIC/S in 2013 and 2016, respectively. The National Medical Products Administration (NMPA) of China also expressed its desire to join PIC/S in 2018 and has been engaged in a series of negotiations.

2. Global distribution of major PIC/S members

(1) Asia: China (TFDA of Taiwan, China; PPBHK of Hong Kong, China), Japan (MHLW, PMDA), South Korea (MFDS), Malaysia (NPRA), Singapore (HSA), Thailand (Thai FDA), Indonesia (Badan POM), Saudi Arabia (SFDA), Israel (ISCP), Iran (IFDA), Turkey (TMMDA).

(2) Europe: Austria (BASG), Belgium (FAGG), Bulgaria (BDA), Croatia (HALMED), Cyprus (CyPHS), Czech Republic (SÚKL, ISCVBM), Denmark (DKMA), Estonia (SAM), Finland (FIMEA), France (ANSM, ANSES), Germany (BMG), Greece (EOF), Hungary (NCPHP), Ireland (HPRA), Italy (AIFA, DGSA), Latvia (ZVA), Lithuania (SMCA), Malta (MMA), Netherlands (IGJ), Poland (CPI), Portugal (INFARMED IP), Romania (NAMMDR), Slovak Republic (SIDC), Slovenia (JAZMP), Spain (AEMPS), Sweden (MPA), Iceland (IMA), Liechtenstein (AG), Norway (NoMA), Switzerland (Swissmedic), United Kingdom (MHRA, VMD), Ukraine (SMDC).

(3) Americas and Other Continents: United States (US FDA), Argentina (INAME), Brazil (ANVISA), Canada (ROEB), Mexico (COFEPRIS), South Africa (SAHPRA), New Zealand (Medsafe).

II. PIC/S Releases "Guideline on the Application for Membership of the Pharmaceutical Inspection Co-operation Scheme" and "Guideline on the Pre-Accession Procedure"

On January 1, 2025, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) officially released two guiding documents, the "Guideline on the Application for Membership of the Pharmaceutical Inspection Co-operation Scheme" and the "Guideline on the Pre-Accession Procedure." These documents provide detailed regulations on the process of applying for PIC/S membership and the operational specifics of the pre-accession phase, which immediately garnered widespread attention from the pharmaceutical industry. So, how much longer does China's NMPA have to go to become a full member of PIC/S?

In fact, as early as September 24, 2021, China's National Medical Products Administration (NMPA) applied to initiate the PIC/S pre-accession procedure. Subsequently, on September 22, 2023, it formally submitted its membership application and received a confirmation letter from PIC/S on November 8. The following day, November 9, the official website of the National Medical Products Administration published "National Medical Products Administration Becomes a Formal Applicant for the Pharmaceutical Inspection Co-operation Scheme." Currently, China's National Medical Products Administration (NMPA) is on the list of applicants for PIC/S membership.

(Source: PIC/S Pharmaceutical Inspection Co-operation Scheme)

This also signifies a further step in the internationalization process of China's drug manufacturing, once again demonstrating China's NMPA's determination and practical measures to accelerate international collaboration. The core bottleneck for Chinese drug exports stems from the mutual recognition barriers of international certifications. For Chinese drugs to enter mainstream international markets, certification hurdles are the primary prerequisite. Joining PIC/S is the key cornerstone for China to achieve mutual recognition of certifications with developed economies such as Europe and the United States.

III. Breaking Through Drug Export Certification Barriers: Malaysia's PIC/S GMP Certification Becomes an Efficient Shortcut for Chinese Pharmaceutical Companies

For Chinese drugs to go global, certification barriers have always been an unavoidable core challenge. Faced with complex and stringent international market access rules, proactive problem-solving is better than passive response – strategically planning the certification path can cleverly resolve this predicament. Among these, obtaining PIC/S GMP certification issued by Malaysia's National Pharmaceutical Regulatory Agency (NPRA) is an efficient and feasible preferred strategy, which can significantly enhance the convenience for Chinese drugs to enter the markets of other PIC/S member countries.

Malaysia is also a full member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The core objective of PIC/S is to promote the harmonization of Good Manufacturing Practice (GMP) standards among its member countries, thereby achieving mutual recognition of regulatory inspection results. This systemic advantage also gives Malaysian PIC/S GMP certification the unique value of "one certificate for multiple countries." The core advantages of Malaysian PIC/S GMP certification are concentrated in these two points:

1. One certification, multi-country recognition, full credibility.

"One certification, global access" is the core highlight of the PIC/S system. Once a Chinese pharmaceutical company passes a rigorous GMP inspection conducted by Malaysia's NPRA based on PIC/S standards and successfully obtains certification, this certificate will have high credibility in over 50 PIC/S member countries and regions worldwide. This means that companies no longer need to invest repeatedly in certifications for different countries; one certificate can unlock multiple key nodes for their international expansion.

2. Reduce repetitive inspections, greatly saving costs and time.

For pharmaceutical companies, the time and financial costs of overseas certification are often high. With a Malaysian PIC/S GMP certificate, companies can often avoid or simplify repetitive on-site inspections by local regulatory authorities when applying for their products to enter other PIC/S member countries. This advantage directly translates into tangible benefits (average approval cycle shortened by 12-18 months), while saving overseas certification costs exceeding tens of millions of yuan per instance, allowing companies to seize international market opportunities with lower costs and faster speed.

For Chinese pharmaceutical companies, being the first to obtain Malaysian PIC/S GMP certification is equivalent to holding an "authoritative pass" to the international pharmaceutical market. It not only helps companies quickly enter the Malaysian domestic market but also serves as a strategic foothold to efficiently radiate the entire Southeast Asian region, and then leverage the vast market of PIC/S member countries globally, laying a solid foundation for internationalization.

Furthermore, as China's formal accession to PIC/S steadily progresses, GMP certificates issued by the National Medical Products Administration (NMPA) will be directly mutually recognized by member countries in the future. At that time, the path for Chinese pharmaceuticals to go global will be smoother, and the international competitiveness of domestic pharmaceutical companies will also see a qualitative improvement.

In the wave of pharmaceutical internationalization, choosing the right certification path is equivalent to seizing the initiative. The unique advantages of Malaysian PIC/S GMP certification provide an efficient solution for Chinese pharmaceutical companies to break through overseas certification barriers, which is worthy of companies' close attention and strategic planning.

(This article is for policy interpretation and knowledge sharing in the medical industry only. The content is for reference only. Please indicate the original source if reprinted.)