| Issue Number : 4217ID See Translation Version

Only certain cost components relating to COVID-19 services can be reimbursed, including costs associated with administration, accommodation, doctors, use of ventilators, medicine, consumable medical treatments, medical devices including personal protective devices, and so forth

| Issue Number : 4191ID See Translation Version

After securing SMKPO certificates, business actors will then be required to: 1) Fulfill the SMKPO standards or commitments within six months of said SMKPO certificates being issued; 2) Possess the SMKPO documents and establish an SMKPO team

| Issue Number : 4175ID See Translation Version

Healthcare facilities that offer telemedicine services during the COVID-19 pandemic comprise the following: 1) Hospitals; 2) Public health centers (puskesmas); 3) Clinics; 4) Independent practices of doctors/dentists and specialists/dental specialists; 5) Medical laboratories; and 6) Pharmacies

| Issue Number : 4147ID See Translation Version

The business activities encompass the following sub-sectors: 1) Pharmaceuticals, health equipment and household health supplies; 2) Health services; 3) Control over vectors and disease-carrying animals

| Issue Number : 4110ID See Translation Version

This Draft Regulation stipulates the standards and requirements that apply across various subsectors of the food and drugs sector, specifically: 1) Drugs; 2) Traditional drugs, quasi-drugs, health supplements and cosmetics; 3) Processed foods; and 4) Imports and exports of food and drugs

| Issue Number : 4094ID See Translation Version

All hospitals must provide isolation spaces that can contain a minimum of 10% of the total number of available hospital beds

| Issue Number : 3984ID See Translation Version

The Government is aiming to procure COVID-19 vaccines and to subsequently implement a widespread vaccination program during 2020, 2021 and 2022 or across a longer timeframe, as stipulated by the Committee for the Mitigation of COVID-19 and National Economic Recovery

| Issue Number : 3963ID See Translation Version

Technical guidance will be implemented in relation to minor findings and/or less than six major findings, while administrative sanctions will be imposed if violations of prevailing laws and regulations are discovered which are not categorized as findings that trigger the implementation of technical guidance

| Issue Number : 3935ID See Translation Version

Guidelines for the assessment of human cell-based medicines which are being aimed at distribution within Indonesia encompass technical requirements for the following areas: 1) Risk analysis; 2) Product quality and manufacturing processes; 3) Non-clinical development; 4) Clinical development; and 5) Pharmacovigilance and risk-management planning

| Issue Number : 3924ID See Translation Version

The National Agency for Drug and Food Control is currently required to issue approvals/rejections for SKI applications within six hours of complete and compliant applications being received, instead of the one business day that was mandated under the previous regulation.

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