FDA denies prolonging private hospitals’ COVID-19 vaccine import requests

[rooster59]

FDA denies prolonging private hospitals’ COVID-19 vaccine import requests

Tanakorn Sangiam

BANGKOK (NNT) - The Food and Drugs Administration (FDA) has insisted the processes involved in importing COVID-19 vaccines have not been delayed, confirming private firms can import the vaccines, provided that all the regulatory requirements are met.

The FDA Secretary General Dr Paisarn Dunkum has addressed a claim made by a private hospital saying they are waiting for FDA processing on the importation of an FDA-authorized COVID-19 vaccine into Thailand.

He said the processes involved require importers to register themselves as certified drug importers, then file for regulatory approval of the model of COVID-19 vaccine they want to import with the FDA, as the importers will be held responsible for the quality and safety of the vaccine they import.

Dr Paisarn said the regulatory approval process, normally takes 30 days once all documents have been submitted, with the approval only for emergency use during the pandemic. He said these vaccines must be administered only at healthcare facilities, with their safety aspects continuously assessed, according to the national COVID-19 vaccination plan set by the Department of Disease Control.

The FDA chief said that the FDA-related processes have not beed delayed, and the agency has opened special channels for companies to file for their regulatory approval, adding that the government is willing to have private hospitals help source and deliver the vaccine to Thai people.

Dr Paisarn mentioned however there is yet to be any private hospital making regulatory filings for a COVID-19 vaccine import with the FDA.

-- © Copyright NNT 2021-03-14

 

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[petermik]

Bu**s*it ????

[Nojohndoe]

Given the motivation for profiteering even by the most respected "private" medical institutions coupled with the fact that as yet any vaccine available is only given "emergency use" approval and as stated is also subject to assessment records post vaccination and  yet further the issue of the difficulty in sourcing any such approved vaccines is it not prudent  for the Thai  FDA to apply limitations?

Note that not one "private" institution has yet applied for import in compliance with the regulatory conditions.

Without compliance to mandatory requirements what is it that at whatever cost is it that would be being pumped into people?

 

 

[Tropicalevo]

43 minutes ago, rooster59 said:

the regulatory approval process, normally takes 30 days

And a report yesterday quoted 90 days for this process.

43 minutes ago, rooster59 said:

Dr Paisarn mentioned however there is yet to be any private hospital making regulatory filings

So they are not exactly overworked with the registration process.

Just more red tape and excuses to delay until the Thai version is working.

[ukrules]

I've said this before and it's still valid, the only important thing in Thailand is the paperwork.

If it takes 30 days then it takes 30 days. they're lucky they don't have a huge number of elderly people who are particularly vulnerable to this virus.

 

Zero preparation and zero urgency.

[hotchilli]

9 hours ago, rooster59 said:

The Food and Drugs Administration (FDA) has insisted the processes involved in importing COVID-19 vaccines have not been delayed, confirming private firms can import the vaccines, provided that all the regulatory requirements are met

We all know how long meeting all requirements takes....

[Ketyo]

Thai government institutions sadly missed the wave of new public management in the 1980s and 90s. Then they missed the post-new public management ideas of the last 20 years. They form a pre-modernization era bureaucratic state. Where having the right papers in place (even if it takes 30 60 90 days) is more important than the end result of saving lives. To make things worse, the PM actually believes that enforcing rules is his main reason for going to work. He doesn't have much of a concept of  system-wide reform and improvement.

[connda]

Thailand is the land of monopolies and monopolies don't like competition.

If this was all about caring about the safety and well being of Thailand and the Thai public during a world-wide declared pandemic, then the FDA should be rubber stamping all the vaccines that are currently being rolled out en-mass in Western countries and other places across the globe - well, except here.  Maybe in April, maybe in June.  Maybe, maybe, maybe private hospitals maybe might possibly will be allow contract and procure currently rolled out vaccines and compete with you know who?  Maybe?  It's pretty difficult not to be cynical when the bureaucracy holding up the show is costing human lives during a Declared Pandemic that threatens the national security of the entire world.  But hey.  The world has too many commoners anyway. Right?  If they get sick and die during the wait, oh well.  Bad karma.  Maybe?  But personally I'm thinking maybe not.  Holding up the procurement and roll-out of vaccine though private hospitals is amoral as far as I'm concerned.  Most of the developed world will be well on to their second set of inoculations before Thai authorities get their act together.  Cui bono?
 
If Terry Gilliam focused on Thailand, he'd have enough material to make:
Brazil 2.0 - Sawatdee and Welcome To The Land of Slow-shots (LOS)

[connda]

11 hours ago, Nojohndoe said:

Note that not one "private" institution has yet applied for import in compliance with the regulatory conditions.

Without compliance to mandatory requirements what is it that at whatever cost is it that would be being pumped into people?

Let me take at stab at this:
The same vaccines that are being "pumped into people" in the US, UK, EU, Israel, and elsewhere in the developed world.  Countries that have already vetted and approved vaccines from major pharmaceutical companies for emergency use for this particular SARS-Cov-2 pandemic. 

So perhaps what is needed is a major push by Thai authorities to keep "compliance with the regulatory conditions" from being an act of gate-keeping for vaccines that are in wide-spread use world-wide - except in Thailand. 

So again.  Cui bono - who benefits?

[GinBoy2]

Without wanting to state, what is probably the obvious.

Isn't the issue, regardless of Thai policies the fact that most of the current vaccine production (non Sinovac) has already been pre-purchased by various countries?

So regardless of whatever comes out of some Thai officials mouth, makes not a jot of difference if the manufacturers have already forward sold countless millions of doses to other customers.

Back to the Chinese I guess, who from the data seem less interested in vaccinating their own population that engaging in vaccine diplomacy!

[Partenavia]

The Thai's did not choose to make early purchases of vaccine, any type, hence the rest of the world now has, therefore the waiting list is long. In addition they choose not to join Covax. 

All the choices have been made by the Thai Government, so there is no one else to blame but them.