IMPROVING BUSINESS ACTORS' COMPLIANCE THROUGH REGULATORY ASSISTANCE IN 2021 – Bekasi, 16-17 September 2021

In the speech of the President of the Republic of Indonesia Joko Widodo in the context of the 76th Anniversary of the Republic of Indonesia on August 16, 2021, it was stated that the independence of the drug and vaccine industry is still a serious weakness that we must solve and the pandemic has accelerated the development of the domestic pharmaceutical industry, including the development of the Red and White Vaccine. Responding to this direction and in order to support national drug and vaccine independence, scientists in Indonesia continue to strive to conduct research and development of drugs and vaccines, not limited to dealing with the COVID-19 pandemic.

The government is committed and working hard, both in terms of regulations and budget policies, for drug and vaccine independence. The role of production facilities, the pharmaceutical industry, and private laboratories in the domestic drug and vaccine development and production ecosystem continues to be improved. In this case, BPOM is ready to oversee the government's commitment to producing safe, efficacious and quality drug and vaccine products, and

In order to accelerate public services, BPOM has made several improvement efforts, including the implementation of the Business Actor Compliance Improvement Through Regulatory Assistance activity by implementing the CAPA desk and the joint use approval desk for drug facilities. With this activity, it is hoped that business actors can implement CPOB and prepare CPOB inspection CAPA properly so that improvements made to the inspection results can be carried out adequately and can accelerate the fulfillment of timeline public services at the Directorate of Drug Production Supervision, NPP. It is expected that with this improvement, customer satisfaction assessments of public services at the Directorate of Drug Production Supervision, Narcotics, Psychotropics and Precursors can also increase.

The implementation of the 2021 Business Actor Compliance Improvement activity through Regulatory Assistance has the following objectives:

1. The results of the POM Agency's evaluation will be clearer and will not cause misperception by the pharmaceutical industry so that improvements by the Pharmaceutical Industry will be faster and the level of compliance of the Pharmaceutical Industry with CPOB will be higher.

2. Strengthening aspects of public services and governance to support bureaucratic reform.

3. Improve the competence of CPOB inspectors.

By holding this activity, it is hoped that the pharmaceutical industry will always be committed to ensuring that CPOB is always implemented and always makes continuous improvements (continuous improvement).