02/07/2020
Dears/ Members of the Chamber
Greetings,
Asharqia Chamber presents you with its best regards and informs you that it has received a letter from the Council of Saudi Chambers No. (KG / 2014) and the date (11/8/1441) and referred to in the Food and Drug Authority’s letter number (29203 / p) and date (2/11/1441), Which includes a reference to the role of the authority in protecting public health and ensuring the safety of medicines, and in completion of the procedures that it takes to ensure that pharmaceutical preparations containing metformin are free of chemical impurities (NDMA) (N-nitrosodimethylamine) that are potentially carcinogenic, and therefore have The authority is studying the topic scientifically and doing laboratory analyzes that have shown the possibility of the appearance of the above-mentioned impurities in some products, which may exceed the acceptable limits for their daily consumption:
1- Performing a laboratory analysis to ensure that all formulations containing metformin containing NDMA are free from distribution or entry into the Saudi market, according to the approved methods of analysis.
2- Submit the results of the analysis as follows:
Summary of results in (Excel) template as follows:
| NDMA level PPB | NDMA Level Ng/1tab | Expiration Date | Manufacture Date | Batch Number | Product Name | Registration number |
B.Attach the following files:
1- Method Validation; according to ICH Q2 R1.
2- Testing Procedure.
3- Submit the results of the above analysis as an administrative transaction with a CD / DVD containing the requirements for the executive management of drug alertness in the medicine sector.
Whereas, the Commission notes that the recommended methods of analysis for the detection of impurities (NDMA) in preparations containing (metformin) are the following:
. LC-HRMS developed and validated by the food and Drug Administration (USFDA(.
.(HRAM-GCMS) developed and validated by the Singapore Health Sciences Authority (HSA).
Sincerely Regard
Attachments2.pdf
