Advices are needed for LTL approach

Hello Everyone,

Last week there was a webinar on Nitrosamine in China, one questions raised by local stakeholder is “what is global regulatory opinion on LTL approach?”. They are asking because majority of antibiotics API are produced in China, some antibiotics MDD are up to 10g, which means the AL will be down to ppb, this is quite a challenge for analytical methods. EMA excluded LTL approach, but the manufacturers are eager to know if there are any successful cases of LTL approach accepted by any regulatory authorities globally.


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Historically, to my knowledge anyway, the FDA has also excluded the LTL approach. PhRMA held a workshop last week where use of LTL approach was discussed, along with some data to support it’s use. What I understood from the speaker was that there is a valid argument for using the LTL approach however, there were no instances provided where the FDA or EMA had allowed it.

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This is very helpful, I will have some chat with local stakeholders and see what approaches they are taking. Thanks.

@ejdowse thank you for sharing the insights from last week’s discussion at the PhRMA workshop.

@jxl Less-Than-Lifetime (LTL) continues to be a center stage topic at any discussion related to limits. Can you elaborate on the concern and proposals from local stakeholders? Did they share why LTL?

We have a great discussion thread where @SusanFelter and @David share their perspectives and agreement on the precautionary approach VS data-based. We have also seen ANVISA (Brazil) including the LTL approach in the guidance draft.

Is LTL approach getting traction and acceptance among regulatory agencies? Any other agency taking Brazil’s position on LTL?

@Naiffer_Host the LTL question was raised by a testing lab, because their customers have some antibiotics with MDD up to 10g, this is a big challenge for them to develop qualified testing method which can detect AL down to ppb, if LTL approach is accepted by regulatory authorities, this will be helpful for them to develop suitable methods.