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Philippines Seeks Feedback On Plan To Recognize BE Studies Under ASEAN Deal

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

Global Pharma Guidance Tracker – Test sabbah

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Pharma Guidance Tracker – August 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: August 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – May 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Pharma Guidance Tracker – April 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Pharma Guidance Tracker – March 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: March 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – February 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: February 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

Philippines FDA Slashes Approval Timelines For Generic Drugs

 
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The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices.

Philippines FDA Slashes Generic Approval Timelines

 
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The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices.

Global Pharma Guidance Tracker – January 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: January 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Stada Pens Philippines Distribution Deal

 
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Stada is looking to grow its reach in the Philippines' consumer health market by signing up Zuellig Pharma as its distribution partner. Separately, the Germany-based firm is working with Pennsylvania's NexGel for an OTC product launch in North America planned for later this year.

Stada And Alvotech Eye Launch Date For Ustekinumab After EU Approval

 
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Stada has revealed details of exactly when in 2024 it plans to launch its Alvotech-partnered Uzpruvo ustekinumab biosimilar to Stelara, having just been granted a pan-European marketing authorization. At the same time, the German firm has also struck a distribution deal for prescription and consumer healthcare products with Zuellig in the Philippines.

Global Pharma Guidance Tracker – December 2023

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.  

Global Medtech Guidance Tracker: December 2023

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Global Medtech Guidance Tracker: November 2023

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – October 2023

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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