ARTA calls FDA to streamline registration process of vaccines
The Anti-Red Tape Authority is calling on the Food and Drug Administration (FDA) to ensure that the process for the Certificate of Product Registration (CPR) for all vaccines and other medical supplies will be streamlined and shall not be subjected to unnecessary processes and requirements.
The FDA previously submitted to ARTA their streamlined process for CPR as well as their automation initiatives. However, some reports to ARTA pointed out that the Pre-Evaluation or Pre-Submission Clearing phase for CPR has caused delays even prior to actual receipt of application.
“The processing time for the CPR should not go beyond 20 days since this is a highly technical transaction. Except for justifiable reasons provided in writing, any applications pending beyond the prescribed processing time is already punishable under Section 21 of R.A. 11032. This point is particularly critical for the approval of CPR for vaccine applications,” reminded Director General Jeremiah Belgica.
ARTA is also recommending to FDA that vaccines and other medical products that have already been cleared by the respective FDAs of other reputable countries be likewise considered as cleared and reliable so as not to belabor the process.
Prior to the pandemic, the FDA has also already been included as one of the agencies involved under the National Effort for Harmonization of Efficient Measures in Inter-related Agencies or NEHEMIA Program of ARTA for the food and pharmaceutical sector. Under the program, the inter-agencies related in the food and pharmaceutical sector, among four other sectors, will be tasked to eliminate overregulation and redundant requirements to come up with a streamlined government process.
Meantime, Belgica has urged all local government units (LGUs) to fully implement their Business One Stop Shops (BOSS)for this year’s business registration and business license renewals.
LGUs’ compliance will be audited based on the requirements of RA11032 and other existing policies on BOSS.
Deficient LGUs shall receive Notice of Deficiencies and may be subjected to a formal investigation which may result to an administrative case, he said.
We are likewise reminding all LGUs that the statutory deadline for the creation of their Electronic Business One Stop Shops (EBOSS) is only until June 17, 2021 which is 3 years from the effectivity of the Ease of Doing Business law.
LGUs with no Electronic BOSS yet may already use the DICT developed Electronic Business Permitting and Licensing System, which is already available for free. This is in line with the President’s directive to bring government transactions and services online.