🇮🇩 Indonesia牌照

印尼MR疫苗安全合规指南：BPOM批准与WHO认证

来源：BPOM · Antara Indonesia发布：2026/3/7

作者：东南亚合规中心编辑团队

TL;DR · 核心要点

印尼卫生部正式确认国家麻疹-风疹（MR）疫苗安全有效，已获食品药品监督局（BPOM）上市许可，并通过世卫组织（WHO）及国家免疫委员会联合评估。关键合规信息包括：疫苗须经BPOM批准方可分发；接种后常见轻微反应（如低热、皮疹）属正常免疫应答，不构成安全风险；MR疫苗使儿童麻疹抗体阳性率从10.41%升至80.21%，风疹从15.10%升至98.96%。对企业的实际影响：在印尼运营的医疗健康企业、疫苗进口商、分销商及国际药企需确保其MR疫苗产品持续满足BPOM注册与GMP要求；开展健康宣导或员工免疫计划的外资企业须依据官方口径传递信息，避免引发合规争议或公众信任风险。

✅ 合规行动清单 · Compliance Checklist

›核查所经销或进口的MR疫苗是否持有现行有效的BPOM注册号（可通过BPOM官网公开数据库验证）
›若为疫苗分销商或医疗机构，须在向公众发布MR疫苗相关信息前，同步卫生部最新声明内容，避免使用未经核实的副作用描述
›制药企业须按BPOM第33/2019号条例提交季度药物流行病学报告（PMS），涵盖接种后不良事件数据

›Verify current BPOM marketing authorization status for all MR vaccines distributed or imported in Indonesia via BPOM’s Public Product Database (https://cekbpom.pom.go.id)
›Align all public-facing MR vaccine communications (websites, brochures, social media) with official Ministry of Health statements — do not characterize common post-vaccination reactions as ‘adverse events’ without clinical confirmation
›Submit quarterly pharmacovigilance reports (PMS) to BPOM per Regulation No. 33/2019, including aggregated data on reported post-immunization reactions for MR vaccines

English Summary

Indonesia’s Ministry of Health reaffirmed the safety and efficacy of the national measles-rubella (MR) vaccine, which holds BPOM distribution approval and WHO prequalification. Key compliance points: all MR vaccines used in national immunization must be BPOM-registered; post-vaccination reactions (e.g., mild fever, rash) are normal and transient—not grounds for product liability or regulatory action; clinical data shows robust seroconversion (measles: 10.41% → 80.21%; rubella: 15.10% → 98.96%). Foreign pharmaceutical companies, importers, and distributors operating in Indonesia must maintain active BPOM marketing authorization and comply with local pharmacovigilance reporting requirements. Employers administering MR vaccination as part of occupational health programs must rely exclusively on BPOM-approved products and align public communications with Ministry of Health statements to avoid reputational or regulatory exposure.

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常见问题解答

我们的公司想在印尼推广MR疫苗，需要哪些许可证？+

必须取得BPOM颁发的《药品市场准入许可证》（IZIN EDAR）和《进口商许可证》（API-U），且疫苗须已完成WHO预认证或BPOM独立质量评估。未持有效IZIN EDAR的产品禁止销售、宣传或分发，违者将被处以最高5年监禁及100亿印尼盾罚款（根据2019年第36号《药品法》）。

员工接种MR疫苗后出现发热，公司是否要担责？+

根据卫生部声明，低热、注射部位疼痛等属于正常免疫应答，非疫苗质量问题。只要使用的是BPOM批准疫苗且接种流程符合《国家免疫技术指南》，企业不承担法律责任。但建议留存接种记录及知情同意书至少5年以备监管核查。

能否用海外版MR疫苗替代印尼BPOM批准版本？+

不可以。印尼实行严格疫苗准入制度，所有在境内使用的MR疫苗必须单独获得BPOM注册批准，即使已在WHO预认证或欧盟EMA批准。擅自使用未注册疫苗将触发BPOM行政处罚及刑事追诉，且无法纳入国家免疫信息系统（SIKImunisasi）。

如何查询某款MR疫苗是否获BPOM批准？+

访问BPOM官方验证平台https://cekbpom.pom.go.id，输入产品名称或注册号进行实时核验。结果页将显示有效期、持证企业、剂型、批号范围及是否列入国家免疫规划（NIP）目录。建议每月复核一次，因注册状态可能动态调整。

外资药企是否需在印尼设立本地实体才能申请BPOM许可？+

是的。根据BPOM第27/2021号条例，境外制造商必须指定印尼本地持牌药品代理（Authorized Local Representative, ALR）作为法律联络方，并由该ALR提交全部注册文件。ALR须持有BPOM颁发的《药品代理许可证》（API-P）并具备GDP资质。

相关关键词

Indonesia MR vaccineBPOM approvalvaccine compliance Indonesiameasles immunization regulationpharmaceutical licensing Indonesia

📄 官方原文参考（英文）点击展开

Indonesia’s Health Ministry on Friday assured the public that the measles-rubella (MR) vaccine used in the national immunization program is safe and effective, urging people not to worry about side effects as measles cases continue to be monitored across the country. The ministry said the vaccine has received distribution approval from the Food and Drug Monitoring Agency (BPOM) and has undergone rigorous evaluation by the World Health Organization (WHO). Lucia Rizka Andalusia, director general for pharmaceuticals and medical devices at the ministry, called on the public to remain confident in the vaccines used in the national vaccination program, particularly for measles prevention. “Do not worry about the vaccines used in the national vaccination program, as they have undergone thorough evaluation by the Ministry of Health in collaboration with the National Immunization Committee,” she said during an online press conference on measles case updates in Jakarta on Friday. She also reminded the public not to be concerned about reactions that may appear after immunization, noting that such responses are generally normal and temporary. Common reactions include mild pain at the injection site, low-grade fever and skin rashes. “Side effects from the MR vaccine are a normal sign that a child’s body is building immunity,” Andalusia said. Related news: Health minister urges immunization amid measles outbreaks Regarding the vaccine’s effectiveness, she said the MR vaccine has proven highly effective in significantly boosting children’s antibody levels, making immunization a key method for protecting against measles and rubella. For measles, she said the vaccine increases protective antibody titers in children from 10.41 percent before immunization to 80.21 percent after vaccination. For rubella, the vaccine raises protective antibody titers in children from 15.10 percent to 98.96 percent. “These data show that the MR vaccine selected for this immunization program effectively provides protection against measles and rubella in children,” Andalusia said. Related news: Indonesia steps up measles surveillance after alert