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BPOM Indonesia and the Jordan Food and Drug Administration (JFDA) convened in Amman on May 21, 2024, with the aim of bolstering their collaboration in pharmaceutical and food supervision. The primary focus of the meeting was to streamline the registration process for Indonesian pharmaceutical products in Jordanian markets. During discussions, Wesal AL Haqaish, General Director Technical Assistant at JFDA, provided updates on the registration progress of Indonesian drug products, including forthcoming inspections for Dexa Medica's diabetes and injection medications, alongside Biofarma's current listing for JFDA inspection.The meeting marked a significant step forward as BPOM and JFDA agreed to intensify their cooperation through knowledge exchange, joint inspections, and regulatory support. Noorman Effendi, Head of Cooperation and Public Relations at BPOM, emphasized their readiness to assist JFDA during inspections of Dexa Medica and Biofarma facilities. Additionally, BPOM proposed to participate as an observer in JFDA's inspections of Indonesia's pharmaceutical industry, aiming to foster mutual learning and best practice sharing in drug supervision.Beyond operational collaborations, both agencies exchanged insights on international regulatory forums and harmonization efforts. Wesal AL Haqaish reiterated JFDA's commitment to elevating regulatory standards, aligning with Global Benchmarking Tools (GBT) maturity level 3 set by the World Health Organization (WHO). Meanwhile, Noorman Effendi highlighted BPOM's strides in obtaining WHO Listed Authority (WLA) status and its pivotal role in Codex standards for global food safety. Looking ahead, BPOM and JFDA are poised to formalize their partnership through a Memorandum of Understanding (MoU) in drug and food supervision, underscoring their joint commitment to enhancing regulatory frameworks and product safety across borders.Reference:https://www.pom.go.id/berita/pertemuan-bpom-dan-jfda-bahas-harmonisasi-regulasi

Refillable cosmetics are products repackaged into containers according to consumer requests at refill facilities. Before being sold, these cosmetics must be officially notified to the authorities. The Indonesian Food and Drug Authority (BPOM) has issued BPOM Regulation No. 12 of 2023 on the Supervision of the Manufacture and Distribution of Cosmetics, which sets forth the guidelines for the use of refillable cosmetics. This regulation aims to reduce plastic waste accumulation in Indonesia through the reuse of cosmetic packaging.The distribution of refillable cosmetics requires compliance with several specific requirements:Cosmetics distributed at refill facilities must have a notification number.Only certain categories are permitted for refillable cosmetics, including liquid body soap, liquid antiseptic body soap, liquid hand soap, shampoo, and conditioner.Products for baby care are prohibited from being sold in refillable form.The sale of cosmetics at refill facilities must be approved by the BPOM Head.The owner of the notification number or the refill facility must: (a) Implement sanitation and hygiene standards, (b) Possess technical documentation, and (c) Have adequate storage facilities.Refillable cosmetic containers must be labeled with at least the following information: (a) Product name, (b) Notification number, (c) Batch number, (d) Name and address of the manufacturer, (e) Filling date, and (f) Expiry date.Before selling cosmetics using the refill mechanism, the products must first undergo notification. If individual business operators possess a notification number, they can apply for a proposal to sell cosmetics at a refill facility by meeting the requirements outlined in Article 16 of BPOM Regulation No. 12 of 2023, which includes: a. Cosmetics distributed at the Refill Facility must have a notification number. b. The Refill Facility must meet the necessary standards. c. A sales cooperation agreement document must be included if the cosmetics are sold by a business operator who is not the owner of the notification number.Reference:PerBPOM No. 12 Tahun 2023 https://standar-otskk.pom.go.id/storage/uploads/b20072a0-eb72-4d89-bbbe-fa4235496da0/PerBPOM-No.-12-Tahun-2023.pdf

Distribution is a crucial aspect in ensuring the quality of pharmaceutical products. To ensure quality throughout the distribution process, product quality needs to be monitored from the moment they enter the warehouse until they reach the hands of consumers. Medical Device Distributors (PAK) are legal entities licensed to procure, store, and distribute drugs and/or pharmaceutical materials in large quantities according to regulatory provisions. The goal is to provide healthcare services where medical equipment distributed can always be effectively functional, including efforts to ensure the provision of safe, reliable, and fit-for-use medical devices.There are some components of requirements that must be fulfilled by a PAK to comply with the CDAKB requirements:Must have a quality management system: A quality management system must be implemented to manage data on acceptance, storage, distribution, and sale of medical devices effectively and in accordance with applicable requirements.Must provide evidence of managing personnel resources related to the operation.Must have buildings and facilities suitable for proper medical device distribution methods.Must have a good inventory storage and handling system.Able to trace products: The company must be able to trace distributed devices by including data containing the customer's name, manufacturer's name, serial number, type, quantity, and marketing authorization number.Handling customer complaints: The company must have an effective customer complaint handling system.Handling Field Safety Corrective Action (FSCA)Must have a system for returning medical devices.Must have a mechanism for medical device destruction.Identification of illegal medical devices that do not meet requirements.Internal audit: The company must conduct regular internal audits to ensure the quality and safety of medical devices.Management review: The company must have an effective management review system to ensure the quality and safety of medical devices.Evidence of controlling third-party activities (outsource activity)Reference:Permenkes No.4 Tahun 2014https://jdih.pom.go.id/download/product/707/4/2014

To ensure the safety, quality, and efficacy of medical devices domestically, and to enhance compliance with the Good Distribution Practices for Medical Devices (CDAKB), the Ministry of Health has issued a new policy as outlined in Announcement Number FR.03.01/E/884/2024.In accordance with the Ministry of Health Regulation Number 4 of 2014 on Good Distribution Practices for Medical Devices, Article 2, Paragraph (1), all medical device distributors and their branches are required to implement CDAKB in their distribution activities. The aim of CDAKB is to ensure that distributed medical devices meet the standards for their intended use. CDAKB provides comprehensive guidelines for organizations involved in the ordering, storage, transportation, and distribution of medical devices.To enforce this, the Ministry of Health will require CDAKB certification for medical device distribution license applications. The implementation will proceed as follows:Socialization for the implementation of CDAKB will take place from May 1 to June 30, 2024, through the regalkes system.The requirement for CDAKB certification in the application for medical device distribution licenses will be enforced starting July 1, 2024.Further information regarding CDAKB certification applications can be found at the link: sertifikasialkes.kemkes.go.id.All stakeholders are encouraged to comply with these regulations to support higher standards in the production and distribution of medical devices within the country.Reference : https://regalkes.kemkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000945

Responding to the increase in non-compliant blue-labeled skincare products, BPOM is stepping up its oversight in beauty clinics nationwide. This effort involves all 76 BPOM technical units across Indonesia and includes a Forum on Regulating Non-Compliant Blue-Labeled Skincare scheduled for May 6, 2024.L. Rizka Andalusia, Acting Head of BPOM RI, emphasized that today's campaign launch aims to educate the public about the safe use of cosmetics, especially non-compliant blue-labeled skincare. These products are labeled with blue tags, often contain strong medications, and are mass-produced and sold online without prescriptions or medical supervision. They're meant for personalized treatments based on doctors' prescriptions for diagnosed conditions.Earlier this year, BPOM inspected beauty clinics nationwide from February 19 to 23, 2024. During this period, they found 51,791 non-compliant cosmetic products worth Rp2.8 billion. These included cosmetics with banned or harmful substances, non-compliant blue-labeled skincare, unlicensed products, beauty injections, and expired cosmetics.Due to the health risks and impact on legal businesses, BPOM stresses the importance of compliance to protect market standards. They've partnered with health associations like IDI and IAI, and gained support from public figures and organizations to enforce regulations effectively.Additionally, BPOM has rallied support through the "BERSERU Together Regulate Blue-Labeled Skincare" initiative from all sectors (government, academia, businesses, communities, and media). They've also launched the Supervision of Blue-Labeled Skincare Regulations program to educate clinic owners and healthcare providers on regulatory requirements for blue-labeled skincare. This includes expert-led seminars on cosmetic oversight at healthcare facilities, led by BPOM, the Indonesian Medical Association, and the Association of Beauty Clinics.The forum aims to strengthen partnerships and ensure effective oversight of non-compliant blue-labeled skincare products. BPOM urges all stakeholders to actively participate in achieving the campaign’s goals.Reference:https://www.pom.go.id/siaran-pers/penertiban-skincare-beretiket-biru-yang-tidak-sesuai-ketentuan

The Product Information File (PIF), known in Indonesia as the Dokumen Informasi Produk (DIP), contains essential information regarding the safety, efficacy, and quality of cosmetics. This documentation is mandatory for the cosmetic industry, importers, and individual/business entities involved in contract manufacturing. The PIF must be prepared by cosmetic manufacturers and importers before a product can obtain notification from BPOM. This is a crucial step to ensure that all cosmetic products entering or produced in Indonesia meet the established safety and quality standards. The Indonesian Food and Drug Supervisory Agency (BPOM) introduced BPOM Regulation No. 17 of 2023 (PerBPOM 17/2023), which concerns the PIF guidelines for cosmetics. This regulation replaces Regulation No. 14 of 2017 (PerBPOM 14/2017) and aims to enhance the safety, efficacy, and quality standards of cosmetics available in the Indonesian market.This regulation introduces several significant changes compared to PerBPOM 14/2017, especially in the areas of safety, efficacy, and quality of cosmetic products. These changes include: Fulfillment of technical requirements for cosmetic ingredients related to safety, efficacy, and/or quality, supported by scientific or empirical evidence Compliance with contamination requirements Results of cosmetic adverse effects monitoring Compliance with labeling requirements Compliance with appropriate claim regulationsThis regulation also modifies the PIF retention period. Manufacturers and importers are now required to retain the PIF for at least one year after the expiration date of the last produced or imported cosmetic. This differs from the previous rule which required the PIF to be retained for up to six years from the date of last production or import. Additionally, any changes in data regarding the safety, efficacy, or quality of the product must be promptly reflected in updates to the PIF, ensuring that the information provided remains relevant and up-to-date. These changes are designed to facilitate the review process and reduce administrative burdens without compromising the quality and safety of cosmetic products.Reference:PerBPOM No. 17 Tahun 2023https://standar-otskk.pom.go.id/storage/uploads/41b90bb4-53cb-48a5-891d-7e6c362528f2/PerBPOM_17_2023-Pedoman-DIP.pdfPerBPOM No. 14 Tahun 2017https://notifkos.pom.go.id/upload/informasi/20181217101014.pdf

Cosmetics containing Alpha Hydroxy Acid (AHA) are commonly used as moisturizers, exfoliants, and chemical peels aimed at brightening the skin. Despite their diverse benefits, improper or excessive use of AHA can pose risks to skin health. Therefore, the use of AHA in cosmetics must be strictly regulated regarding both concentration percentages and application procedures.According to BPOM Regulation No. 30 of 2020, cosmetics containing AHA are classified based on AHA concentration and application methods:Group 1: Products applied by consumers themselves, containing up to 10% AHA with a pH of 3.5 or higher. These products can be distributed directly to the public.Group 2: Products that must be applied by a doctor, containing more than 10% up to 20% AHA with a pH of 3.0 or higher. These products can only be distributed to doctors.Group 3: Products that must be applied by a dermatologist and venereologist, containing more than 20% up to 30% AHA with a pH of 3.0 or higher. These products can only be distributed to specialists in dermatology and venereology.To ensure the safe use of cosmetics containing AHA, each product must include the following warnings:A. General Warnings:For cosmetics with AHA concentrations ≥ 2.5%:If hypersensitivity reactions (such as burning, redness, or other signs of irritation) occur on the skin, discontinue use and consult a doctor immediately.Avoid direct sun exposure during use.Do not use around the eyes, mouth, or other mucous membranes.Additional warnings for cosmetics used on body areas exposed to sunlight with AHA concentrations ≥ 2.5% that do not contain sunscreen or contain sunscreen with ineffective concentrations must include warnings about sun protection.B. Specific Warnings:Warning for Group 2 AHA-containing skin cosmetics: "For application by doctors only.”Warning for Group 3 AHA-containing skin cosmetics: "For application by dermatologists and venereologists only."Reference:https://jdih.pom.go.id/download/product/1202/30/2020

The Ministry of Trade (MoT) conducted an online socialization regarding Minister of Trade Regulation (Permendag) No. 8 of 2024 to business stakeholders. Permendag 8 of 2024 contains the Third Amendment to Minister of Trade Regulation No. 36 of 2023 concerning Import Policies and Regulations. The socialization, held online on Tuesday (21/5/2024), was attended by business stakeholders, including importers and manufacturer-importers.Three speakers were present at the socialization: Director of Imports at the MoT, Arif Sulistiyo, Technical Director of Customs Affairs at the Ministry of Finance, R. Fadjar Donny Tjahjadi, and Director of Business Process Efficiency at the National Single Window Institution (LNSW) of the Ministry of Finance, YFR Hermiyana. During the socialization, seven provisions in Permendag No. 8 of 2024 were discussed.The first provision involves relaxing the requirements for Import Approval (PI) for Importers with Manufacturer Identification Number (API-P) for 18 specific commodities, which no longer require technical considerations. The second provision entails relaxation of imports for eleven commodity groups encompassing various items such as electronics, traditional medicines, cosmetics, clothing, and others. The third provision relates to relaxation of release of certain imported goods arriving at ports between March 10, 2024, and May 17, 2024, with at least 26 thousand containers affected by this condition. Meanwhile, the fourth provision discusses exceptions to import prohibitions and restrictions (lartas) for iron, steel, and its derivative products with a maximum limit of USD 1,500 per shipment for Importers with API-P. The fifth and sixth provisions introduce simplification of requirements and additional exceptions to import prohibitions for sample goods and personal shipments not for business purposes, including exemptions for hazardous and prohibited goods. Finally, the seventh provision regulates the import provisions for personal belongings such as mobile phones, handheld computers, and tablets into the Free Trade Zone and Free Port (KPBPB), with a maximum limit of two units per arrival per year."We hope that the government's swift action in issuing Permendag No. 8 of 2024 can overcome various obstacles in the import process and support smooth trade in Indonesia," said Director of Imports at the Ministry of Trade, Arif Sulistiyo.Arif also added that with this new policy, the government is committed to continuously listening to and responding to input from business stakeholders to create a more conducive business environment and support national economic growth.Source : https://www.tvonenews.com/ekonomi/212269-digelar-daring-kemendag-sosialisasikan-permendag-nomor-8-tahun-2024-kepada-pelaku-usaha-dan-importir-simak-isi-lengkapnya