Abstrak
Dalam rangka kemudahan berusaha dan percepatan proses perizinan, pemerintah telah melakukan simplifikasi regulasi terkait perizinan berusaha termasuk dalam bidang distribusi obat dengan menerbitkan PP No. 5 Tahun 2021 dan PerBPOM No. 10 Tahun 2021. Berdasarkan regulasi tersebut, terdapat perubahan persyaratan dalam proses sertifikasi CDOB diantaranya pemangkasan timeline proses sertifikasi CDOB baik dari pihak BPOM maupun pelaku usaha, serta simplifikasi jenis sertifikat CDOB. Tujuan penelitian untuk mengetahui implementasi kebijakan sertifikasi CDOB sebagai standar perizinan berusaha di Indonesia. Penelitian menggunakan pendekatan kualitatif dengan wawancara mendalam dan telaah dokumen. Penelitian menggunakan teori analisis kebijakan Van Meter dan Van Horn dengan variabel ukuran dan tujuan kebijakan, sumber daya, karakteristik badan pelaksana, komunikasi, disposisi pelaksana, serta lingkungan ekonomi, sosial dan politik yang mempengaruhi implementasi kebijakan. Hasil penelitian adalah ukuran dan tujuan kebijakan serta disposisi pelaksana telah jelas dan dipahami namun masih terkendala pada aspek sumber daya (anggaran), komunikasi, dan karakteristik badan pelaksana dalam hal keterbatasan SDM dan fasilitas khususnya di instansi pemerintah, serta lingkungan ekonomi, sosial dan politik turut berpengaruh pada implementasi kebijakan sertifikasi CDOB sebagai standar perizinan berusaha. Kesimpulan: implementasi kebijakan sertifikasi CDOB sebagai standar perizinan berusaha belum berjalan secara optimal karena masih terdapat perubahan kebijakan yang belum diimplementasikan terkait simplifikasi jenis sertifikat CDOB.
In the context of facilitating doing business and accelerating the licensing process, the government has simplified regulations related to business licensing, including in the field of drug distribution by issuing Government Regulation Number 5 of 2021 and BPOM Regulation Number 10 of 2021. Based on these regulations, there are changes to the requirements in the GDP certification process included trimming the timeline for the GDP certification process both from the BPOM and business actors, as well as simplification of the types of GDP certificates. The research objective is to determine the implementation of the CDOB certification policy as a business licensing standard in Indonesia. The research uses a qualitative approach with in-depth interviews and document review. This study uses the theory of policy analysis by Van Meter and Van Horn with the variables of policy size and objectives, resources, characteristics of implementing agencies, communication, disposition of implementers, as well as the economic, social and political environment that influences policy implementation. The results of the research are that the size and objectives of the policy as well as the disposition of the executors are clear and understood but are still constrained in the aspects of resources (budget), communication, and the characteristics of the implementing agency in terms of limited human resources and facilities, especially in government agencies, as well as the economic, social and political environment. influence on the implementation of the GDP certification policy as a business licensing standard. Conclusion: the implementation of the GDP certification policy as a business licensing standard has not run optimally because there are still policy changes that have not been implemented regarding the simplification of the GDP certificate type.