5 January 2021 – The Anti-Red Tape Authority (ARTA) 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 applications for the COVID-19 vaccines”, 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 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.