Medical writing in China
Medical writing in China developed alongside regulatory reform, expanding drug development and demand for English-language scientific publication. Its professional community, bilingual regulatory work, training routes and public-facing science writing reflect those conditions.
Regulatory reform
In 2015, China required local clinical data and documents beyond the Common Technical Document (CTD) for new drug applications for imported products, and its regulator was not yet an ICH member. The China Food and Drug Administration became a regulatory member of the International Council for Harmonisation at its Montreal assembly of 31 May–1 June 2017. The Center for Drug Evaluation was translating US Food and Drug Administration (FDA) guidelines into Chinese in 2018 to help regulatory staff learn from US experience and Chinese companies prepare for global markets.
Early-2018 implementation of ICH M4, E2A, E2D, M1 and E2B(R3) introduced CTD modules and standards for safety reporting. New 2018 procedures included pre-IND meetings, optimised approval times of 60 working days for investigational new drug (IND) applications and 150 for new drug applications (NDAs), and a single IND approval covering phases I–III; the average IND wait had been 14 months in 2013–2015. Urgently needed drugs already approved in Japan, the EU or US could apply directly for marketing if ethnic insensitivity was demonstrated. By September 2019, a trial could proceed if the authority made no comments within 60 working days of a written clinical-trial application.
China’s National Medical Products Administration (NMPA) sought public comments on electronic CTD implementation in 2019 and planned electronic regulatory submissions. A 2020 account distinguished eCTD use in most global or regional studies from its absence in local studies. Digital regulatory archives had been implemented by several global pharmaceutical companies in China from 2008, and parallel document-review software such as PleaseReview had been recommended from 2013.
Workforce and recognition
By 2018 China was the world’s second-largest pharmaceutical market, with growing multinational investment and Chinese companies expanding at home and globally.
Dedicated regulatory-writing roles were initially uncommon: writing was handled in broader medical-affairs or clinical-development departments. Multinationals are believed to have introduced specialist regulatory writers, needing local bilingual staff even when headquarters prepared global documents. They initially used China-based contract research organisations (CROs), whose quality varied when writing was not a core competence, then increasingly recruited and trained local teams, especially around Chinese research centres. By 2015, changing regulation, accumulating Chinese patient data and demand for publications in English and Chinese were encouraging global pharmaceutical companies and CROs to establish small teams, with few available candidates and widely differing scopes of work. In 2018, experienced bilingual writers were seen as becoming essential both to multinationals entering China and to Chinese companies entering global markets.
A 2018 practitioner estimate put the regulatory-writing workforce at at least a few hundred, compared with fewer than a few dozen a few years earlier; accurate counts were lacking. A separate 2020 estimate put regulatory and publication writers at pharmaceutical companies and CROs at 200–300 in 2019, compared with almost no dedicated document-writing professionals before 2000. Chinese biopharmaceutical companies and local CROs were also using professional writers by 2018, including startups led by overseas returnees who understood the value of protocols, clinical study reports and CTDs. CRO services in China included regulatory and publication writing, with a growing industry of global branch offices and local firms by 2020. A 2019 practitioner account described most Chinese writers as preferring pharmaceutical companies because of that employment market’s size and growth, while anticipating more CRO writing opportunities as research budgets increased.
Senior writers interviewed in 2018 described difficulty persuading management that document development needed a specialist, while clinical research physicians were occupied with monitoring and investigator communication. Writers brought daily writing practice but still needed physicians’ therapeutic expertise. Tighter Chinese requirements for global companies and the global ambitions of local companies created demand that met a limited, inexperienced writing workforce. In 2018, CTD experience was scarce, creating a steep learning curve for local writers and opportunities for experienced overseas writers to lead teams or provide training.
Medical peers could misunderstand the job. In 2019, a practitioner with 14 years’ experience still encountered medical peers who understood writers as copying text, correcting spelling or preparing tables rather than creating original scientific and regulatory documents. In 2022, a Chinese medical-writing leader described growing recognition of the role in China and expected this to extend across developing Asia-Pacific regions.
The professional community
Local writers proposed a formal organisation in late 2013, held a first forum for about 30 writers and submission specialists in Beijing on 21 March 2014, and officially announced the China Medical Writers Community (CMWC) at DIA China’s annual meeting in May 2014. CMWC became DIA China’s seventh community, under DIA’s global medical-writing community. Members speaking in 2015 and a 2018 account dated its formation to 2013, while writers interviewed in 2018 dated the coming together of the community to 2014. Its stated goals in 2015 were to:
- Promote excellence in medical writing in China.
- Provide knowledge sharing among medical writers working in China.
- Bridge differences in understanding of medical-writing practice between China and elsewhere.
By 2015 CMWC had more than 100 members, mostly employed by global pharmaceutical companies or CROs in China, and a nine-person core committee with membership, communication and Beijing and Shanghai education coordinators. Committee posts were intended for three-year terms. It ran four forums between 2014 and mid-2015, collected feedback after each, planned two annual forums in Beijing and Shanghai, and used WeChat for spontaneous discussion while developing a website. About a third of members attended the March 2015 forum in person, with more joining online. Discussion covered ICH documents, including clinical study reports and CTDs, and Chinese authority requirements. Many CMWC members had belonged to international associations and regularly attended their training in 2015.
At the 2015 DIA China meeting, CMWC hosted a full-day preconference workshop and four sessions.
- Lean approaches to clinical, chemistry-manufacturing-and-controls and nonclinical documents.
- The evolution and expansion of medical writing from global practice to China.
- Innovation in a changing environment.
- Professional writers’ contribution to scientific publication in China.
- CTD, ICH E3-compliant clinical study reports and Chinese submission dossiers.
CMWC described this as China’s largest medical-writing gathering to that date. By 2018 the community combined twice-yearly education with online knowledge sharing, and its WeChat group had 400–500 members in 2019. A medical-writing leader who relocated to Shanghai recalled in 2026 that she helped establish a local organisation whose first 30-person meeting became a regular event, with a WeChat knowledge-sharing group of more than 500 writers before her departure.
Bilingual regulatory work
A 2024 account described Chinese regulatory writers supporting clinical-trial, investigational new drug, new drug and biologics licence applications to the FDA, European Medicines Agency (EMA) and other authorities while prioritising NMPA submissions, requiring equal proficiency in Chinese and English. Global-submission documents were usually drafted directly in English; for China submissions involving non-Chinese team members, writers might draft in English and translate the final text, or agree the results and content strategy in English before drafting in Chinese with the local team. In simultaneous China and global submissions, writers bridged local and global teams, kept documents consistent and helped choose the authoring language. Where English was primary, they needed concise text for translation, translation-process and timeline management, and coordination with regulatory affairs on accurate, consistent Chinese versions.
Training and development
China had no formal medical-writing degrees or education programmes at universities or related nonprofit institutions in 2024. Many writers learned through employer procedures, work instructions, ICH-based templates and past documents, with some receiving shadowing or coaching from senior colleagues. Access to American Medical Writers Association (AMWA), European Medical Writers Association (EMWA) or International Society for Medical Publication Professionals (ISMPP) education was described as rare; CMWC’s annual conference and medical-writing content at Chinese Medical Affairs and DIA conferences offered knowledge exchange.
A 2024 regional training assessment identified a need for more systematic programmes, clearer career paths and cross-cultural communication. It considered deriving much of the China-subpopulation report from a global report a limit on some writers’ development, while local companies’ global registrations created opportunities to write English reports under ICH guidance. Targeted online training at Asia-Pacific-friendly times was proposed to meet these needs.
Scientific publication and editorial services
By 2018, government research support and institutional incentives for publication, including recognition, career advancement and cash rewards, had driven steep growth in Chinese scientific output. China accounted for about 19% of 2.3 million English-language peer-reviewed research articles in the 2018 global publishing report, ahead of the US at 18%. Publication pressure, especially for high-impact English-language journals, accompanied misconduct investigations exposing plagiarism, falsified data, purchased authorship and manipulated peer review. The China Association for Science and Technology was implementing fraud-prevention programmes in 2018.
Demand for help publishing in English encouraged growth in editorial services. The number of providers was unknown; an Alliance for Scientific Editing in China estimate suggested nearly a thousand, while a 2018 practitioner assessment considered only a handful transparent and ethical. Misconduct damaged legitimate providers’ reputations, and researchers unfamiliar with publication ethics could confuse legitimate support with improper services and hesitate to acknowledge assistance. The 2018 practitioner assessment expected demand for ethical services to remain high, with education, updated guidelines and government regulation gradually improving publishing quality.
Popular science and Chinese media
Popular-science writing for the Chinese public began under the Ministry of Culture in the late 1940s, stagnated during the Cultural Revolution and revived after the 1970s as the government encouraged scientific associations to disseminate findings. Publishers, science-communication agencies and members of the public later joined the work. A science-agency writer interviewed in 2018 described content ranging from diseases, remedies and doctor–patient communication to emerging research, often adapted from overseas journals or agencies. English-language material required translation and adaptation for Chinese habits, culture and relevance.
China’s regulated internet shaped dissemination: WeChat, Sina Weibo and Tencent QQ were prominent platforms in 2019, with mobile apps replacing websites for many businesses. Hospitals, for example, might offer appointments and current information through WeChat mini-programmes despite having no current website. By the end of 2017 China had 772 million internet users, 98% active on mobile. Science campaigns therefore needed to account for Chinese platform practices, and skill with those platforms could be valuable depending on the writer’s purpose.