Direct answer: Separate three tracks—internet drug-information filing, the pharmacovigilance (PV) reporting route and clinical-trial information. Acceptance checks the filing number, reporting clock, content approval, privacy and evidence, not just a polished page.
This guide is for marketing, regulatory, PV, medical, legal, IT and website-vendor teams at Taizhou pharmaceutical and medical-device companies. It covers whether a website needs a PV/clinical-trial page, what to publish and how to accept it. Information is current to 30 October 2026. It is public regulation, regulatory notices and project method, not legal, registration, medical or compliance advice; filing, advertising review, PV timelines and page content are governed by current rules, provincial regulator requirements, company SOPs and contracts.
Taizhou pharma/device companies often combine local registration/manufacturing with out-of-town or export customers; website content is usually led by marketing and reviewed by regulatory, PV and medical teams, so cross-team delivery and evidence are the acceptance challenge.
A website is not a trial registry or an advertising slot. Confirm whether the site provides internet drug/device information, make the PV route usable, recorded and time-bound, and keep clinical-trial content consistent with the official registry—no recruitment without ethics approval.
Which three tracks matter in 2026?
Publishing drug/device information may trigger filing; PV needs a usable website reporting route; clinical-trial information must match the official registry and must not become recruitment or an efficacy advertisement.
Pharma websites often mix three different jobs: product introduction, adverse-event reporting and clinical-trial information. They have different regulatory logic and page owners. The product page explains what the company does; the PV page explains how to reach the company after an adverse event; the clinical-trial page explains whether the information is accurate, whether recruitment is open and how subject rights are protected. None of them can be replaced by a generic "contact us" form.
| Track | What the page must do | What it cannot replace | Acceptance evidence |
|---|---|---|---|
| Internet drug/device information service | Assess whether the site provides an information service; file under current rules; display the number; operate content review | Product registration/filing, manufacturing/distribution licences | Filing number, entity/domain, content list |
| Pharmacovigilance (PV) | Publish a usable phone/email/form or routing note; privacy notice; records, assessment and clock | PV system, medical assessment, regulatory reporting | Entry screenshot, test record, SOP, clock |
| Clinical-trial information | Registry number, phase, sites/recruitment status, official registry link; recruit only after ethics approval | Official registry, ethics review, informed consent | Registry record, ethics approval, version/approval |
| Product/advertising claims | Stay within the approved label/IFU; advertising review where applicable; medical/legal review | Advertising approval number, registration/filing evidence | Label/IFU, approval, review record |
The three tracks are an editorial framework for page ownership; whether a site provides an internet drug/device information service or needs advertising review depends on its actual content, product/market and the provincial regulator.
If the website publishes drug information, is the old certificate still enough?
China changed drug/device internet-information approval to filing in 2025. An existing certificate remains valid until expiry, after which the company files; the homepage must display the filing number and each website/app is filed separately.
This is where old templates go wrong. A 15 January 2025 notice from the National Medical Products Administration changed "drug and medical-device internet-information service approval" to filing management from 20 January 2025. Companies that already held an Internet Drug Information Service Certificate could continue until the certificate expired and then file. The filing regulation issued on 19 December 2025 requires filing by website, client and application, and continuous display of the filing number in a prominent place on the homepage or main page.
So in 2026, do not ask only "do we have a certificate?" Ask what the site actually publishes, whether it provides a drug/device information service, whether the filing entity and domain match, whether the homepage number is current, and whether staffing, procedures and change notifications meet the rules. An unexpired certificate still matters, but "the certificate has not expired" is not a reason to ignore filing, content review or change management.
| Item | Old certificate | Current filing | Acceptance evidence |
|---|---|---|---|
| Process | Provincial approval, then certificate | File with the provincial regulator before providing the service; obtain a filing number | Filing record, number, entity/domain |
| Homepage display | Certificate number in a prominent place | Filing number continuously displayed on the homepage/main page | Homepage screenshot, verifiable number |
| Staff/procedures | At least two people familiar with drug/device rules or professional knowledge | At least two people familiar with the rules/professional knowledge, or qualified pharmacy/device technical staff | Staff list, qualifications, procedures |
| Changes | Follow certificate change requirements | Name, legal representative/contact, address, site/app name and domain changes: file change within 30 days | Change record, timestamp |
| Content limits | No product information for narcotics, psychotropics, toxic, radioactive, rehabilitation drugs or hospital preparations | Same prohibited products; published information must be lawful, true, accurate and complete | Content list, review record |
| Nature | Administrative approval | Filing is not a quality certification and does not replace product registration/manufacturing licences | Do not call the filing a "certification" |
The certificate/filing comparison is editorial; transition, certificate expiry, materials and acceptance practice depend on the provincial regulator's current requirements.
For product registration/filing, indications and advertising claims, see "How Should a Taizhou Pharma/Device Manufacturer Accept Its Website?". This article does not repeat that registration/label checklist.
What is the minimum viable pharmacovigilance page?
At minimum: a usable phone/email, a report form or routing note, a privacy notice, a PV recipient and clock, human review and records. A sales@ mailbox alone is not a completed PV route.
Article 35 of China's Good Pharmacovigilance Practice (GVP) requires the marketing authorisation holder to collect suspected adverse-drug-reaction reports from patients and others through channels including the phone number or email published on the product label, packaging and portal website, and to keep those channels open. For a corporate website, that means the PV route cannot be just a sales mailbox in "Contact us". It needs a clear path, a usable phone/email or form, and a recipient who can route the report into PV.
Article 49 sets the individual-case clock: serious adverse reactions should be reported as soon as possible and no later than 15 days after the holder first becomes aware; non-serious reactions no later than 30 days. The website form is an intake point, not the PV system. If a report lands in a sales inbox and nobody forwards it, the clock still started when the company first became aware. Test the path with a fictitious report—submit, receive, PV triage, record—and never use real patient information for testing.
Reports may contain patient health data, which is sensitive personal information. Check the form and records against the Personal Information Protection Law, Articles 28 and 29, for purpose, necessity, strict protection and separate consent/notice.
| Page element | Pass standard | Evidence | Common failure |
|---|---|---|---|
| Entry point | Reachable within two clicks from home/footer/product page: "adverse reaction / pharmacovigilance" | Entry screenshots, navigation path | Buried under investor relations |
| Phone/email | A working PV phone or dedicated mailbox, not sales@ | Number/mailbox, duty note | Sales address only, or a dead line |
| Report form | Enough fields but no excessive data; attachment option; privacy notice | Fields, notice text | Requires diagnosis/records before submission |
| Privacy notice | Purpose, scope, retention, sharing, rights and contact | Privacy policy, consent box | Pre-ticked box, no health-data explanation |
| Routing | Named PV recipient/backup; sales/support know how to forward | Routing table, SOP, training | Email lands in a sales pool |
| Clock | First awareness enters PV; serious 15 days/non-serious 30 days | Test record, clock, SOP | Waiting for marketing to clean it up |
| Records | Submission, forwarding, assessment, report and closure are traceable | Logs, tickets, versions | Screenshots of chat messages |
| Training | Marketing/support/distributors know a suspected reaction is not an ordinary lead | Training sign-in, Q&A | Only the PV team knows the route |
The checklist is an editorial suggestion; PV system, reporting clock, delegation and records are governed by the GVP, company SOPs and regulator requirements.
What can a clinical-trial page say—and what must it avoid?
It can publish the registry number, indication, phase, sites/recruitment status and an official registry link. It cannot replace the registry, recruit without ethics approval, promise efficacy or expose subject information.
The primary source for clinical-trial information is not the company website; it is the regulator's trial registry and disclosure platform. The website can explain already-registered information in plain language and link to the official record. It should not become the only registry, or use "recruitment", "free treatment" or "significant efficacy" to pull patients in. China's GCP requires trials to meet ethical requirements; ethics review and informed consent are key protections, and investigators must protect subject privacy and confidentiality.
If the site publishes recruitment information, confirm the ethics approval, recruitment materials, informed consent and contact route are approved first. If it only describes completed trials, avoid unpublished data, subject stories and efficacy comparisons that read like advertising. Give the page a version number, medical/regulatory approver and update date, and take it down or update it when trial status changes.
| Content | Public? | Condition | Evidence |
|---|---|---|---|
| Registry number/title | Yes | Match the official registry; name the registry and date | Registry screenshot/link |
| Indication/phase | Yes | Within the registered/protocol scope; no efficacy promise | Protocol/registry record |
| Sites/recruitment status | Yes | True status and update date; site/contact authorised | Site list, authorisation |
| Eligibility criteria | Caution | Official registry/investigator explanation; not a substitute for medical judgement | Protocol, ethics approval |
| Results/papers | Yes | Already public/published; cite the source; no selective quoting | Paper/conference abstract |
| Subject stories | Not recommended | Even with consent: de-identify and avoid inducement; no efficacy promise | Consent, ethics/legal advice |
| Recruitment/contact | Conditional | Ethics approval, informed consent, approved recruitment materials; no urgency pressure | Ethics approval, recruitment materials |
Clinical-trial page boundaries are editorial; registration, recruitment, informed consent, privacy and advertising requirements depend on the GCP, ethics committee, regulator and product/market.
How should the filing, pages and reporting route be accepted?
Accept seven items: filing, content, entry, clock, privacy, records and updates. Each needs an owner, evidence and a failure path—not just a live page.
The checklist can be shared by marketing, regulatory, PV, medical, legal, IT and the website vendor. The pass standard is not "the page looks professional". It is: the filing number can be verified, the PV route works, content is approved, reports have a clock, privacy is disclosed, records are traceable and changes can be taken down.
| Check | Pass standard | Evidence | If failed |
|---|---|---|---|
| Filing entity/number | Entity, domain and site name match; homepage number verifiable; changes filed | Filing record, homepage screenshot | File/change before launch |
| Content scope | Drug/device information within approval/registration; no prohibited products | Content list, review record | Remove/revise/add evidence |
| PV entry | Phone/email/form usable; two clicks; privacy notice | Entry screenshot, test record | Fix navigation/recipient |
| Test report | Fictitious report reaches PV; triage, record and clock traceable | Test ticket, logs | Redo routing/training |
| Privacy | Health data minimised; separate consent/notice; access controlled | Privacy policy, access log | Disable form/add consent |
| Records/clock | First awareness, forwarding, assessment, report and closure recorded; serious 15 days/non-serious 30 days | SOP, clock, reports | Add records/fix process |
| Updates/removal | Trial status, certificates, staff, contacts can be updated; old versions traceable | Version table, update log | Assign owner/expiry alert |
The acceptance checklist is an editorial suggestion; filing, PV, clinical-trial and privacy requirements depend on the rules, provincial regulator, ethics committee and company SOPs.
For a fuller website-form, cookie and privacy-notice checklist, see “China's PIPL Compliance Audit in 2026”.
How should the work be sequenced over 90 days?
Weeks 1–2 inventory and assign owners; weeks 3–4 filing/content; weeks 5–6 pages/forms; weeks 7–8 testing/training; weeks 9–12 launch, review and name the next review owner.
Do not wait until after a website redesign to add PV and clinical-trial pages. Inventory existing pages, certificates/filings, products/trials and reporting routes first, then decide what goes live, what only links to the official registry and what must be removed. Filing and content review can run in parallel with design, but testing and training must finish before launch.
| Phase | Actions | Outputs | Owner |
|---|---|---|---|
| Weeks 0–2 | Inventory site content, filing/certificate, products/trials, PV entry and SOPs | Gap table, scope, owners | Marketing/regulatory/PV |
| Weeks 3–4 | Decide the filing path, content list, registry links and approvers | Filing plan, content matrix | Regulatory/legal |
| Weeks 5–6 | Revise pages/navigation/forms/privacy notice; set PV routing | Prototype, forms, SOP | IT/marketing/PV |
| Weeks 7–8 | Test with a fictitious report; train marketing/support/distributors; review content | Test record, training record | PV/QA |
| Weeks 9–10 | Launch; check filing number, entry, links, mobile and privacy | Launch checklist, screenshots | IT/marketing |
| Weeks 11–12 | Review routing/clock/content updates; set the next review | Review table, update plan | PV/regulatory |
The 90-day plan is an editorial suggestion; filing acceptance, ethics approval, content review and launch timing depend on the company, regulator and vendors.
Who should read this, who should not, and what decision does it support?
It fits Taizhou companies with marketed drugs/devices, a website publishing product information or clinical trials. It does not fit a corporate-only site with no drug information, or a team without PV/medical ownership.
Who should read: marketing, regulatory, PV, medical, legal, IT and website vendors at Taizhou pharma/device companies; teams redesigning a website, preparing for export, asked to add a PV entry or planning to publish clinical-trial information; anyone deciding whether to file, what to publish, how reports should flow and how to accept the page. Who should not: companies whose site only covers corporate news, recruitment or investor relations and publishes no drug/device information; teams without a PV/medical owner or a clear content owner; projects expecting a page guide to replace filing, ethics review or legal advice. Decisions supported: filing path, minimum PV page, clinical-trial disclosure boundaries, privacy/records/clock, a 90-day plan and launch acceptance.
Lingyi Information is a website and AI project services company, not a drug-registration, PV or legal firm. This article does not replace filing agents, ethics review, medical assessment or legal advice. Taizhou projects are confirmed case by case for remote or on-site work; Lingyi is one candidate, not a local office/team, and does not promise filing approval, reporting deadlines or regulatory outcomes.
FAQ
Does a corporate-news-only website need filing?
Look at what the site actually publishes. A company profile, recruitment and investor-relations site usually does not provide drug/device information; if it publishes products, labels, indications, PV or clinical-trial information, assess whether it provides an internet drug/device information service under the current rules. The company and provincial regulator should confirm based on actual content.
Can we still use the old Internet Drug Information Service Certificate?
A certificate obtained before the approval-to-filing change remains valid until expiry; after expiry, continue the service by filing. Do not assume that holding a certificate removes the need for filing, homepage display or content-change management. Materials and transition practice depend on the provincial regulator.
Can the PV page use a sales@ mailbox?
Not recommended. The GVP requires a portal-website phone or email channel and an open route; a sales mailbox without PV receipt, triage and clock records can turn a suspected adverse reaction into an ordinary lead. Use a dedicated mailbox/phone/form and name a PV recipient and backup.
Can the website recruit clinical-trial subjects?
Only after ethics review, informed consent and recruitment-material approval, and even then without inducements such as "free treatment" or "significant efficacy". The site should link to the official registry and match the approved protocol, ethics submission and actual sites.
Is the company website the authoritative source for trial information?
No. The website can explain and link, but registration and disclosure should follow the regulator's official platform. Keep the site consistent with the registry, show the update date and do not use the site to disclose unpublished data.
How often should the page be reviewed?
Update immediately when a product, certificate, trial status or contact changes; even without changes, check the entry, links, privacy notice and routing quarterly, and do a full review annually. The exact frequency depends on the SOP, PV system and regulator.
Bottom line
For a Taizhou pharma website, separate filing, the PV route and clinical-trial information. The filing number must be verifiable, the PV route must work and feed the 15/30-day reporting clock, and trial content must match the official registry without crossing ethics or advertising boundaries. Pages, privacy, records and updates all need an owner and evidence.
Method and limits
This article is public regulation, regulatory notices and editorial method, not certification, a compliance opinion or legal advice for any company, product, website, filing or clinical trial. It uses no unpublished client materials, patient data or regulatory case files. The page checklist, tables and 90-day plan are editorial suggestions; filing, PV, clinical-trial, privacy and advertising requirements are governed by current rules, the provincial regulator, ethics committee, company SOPs and contracts.
Sources
Information is current to 30 October 2026; each official/primary page governs its own scope and version.
- Good Pharmacovigilance Practice (NMPA Announcement No. 65 of 2021, effective 1 December 2021): gov.cn. Article 35 portal-website phone/email channel; Article 49 serious 15-day/non-serious 30-day reporting clock.
- Good Clinical Practice for Drug Trials (No. 57 of 2020, effective 1 July 2020): gov.cn. Ethics review, informed consent, subject rights and privacy.
- Provisions on Filing for Internet Drug and Medical-Device Information Services (No. 123 of 2025, effective 19 December 2025): gov.cn. Filing unit, two technical staff, homepage filing number, 30-day changes and content limits.
- NMPA General Office notice on implementing reform pilot experience (15 January 2025): gov.cn. From 20 January 2025, drug/device internet-information approval became filing; existing certificates continue until expiry, then file.
- Personal Information Protection Law of the PRC: npc.gov.cn. Medical health is sensitive personal information; processing needs a specific purpose, necessity, strict protection and separate consent (Articles 28 and 29).