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<span style="font-size:14px"><strong><span style="color:#7f8c8d">Podcast hosted by PharmaSources</span></strong></span></span><br />
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<img src="https://info.cphi-chinaedm.com/mailings/45/30687/ep19_square_round.png" alt="Episode19: EU issues GMP Annex 1 final revision for sterile drug products" border="0" width="107" style="display:block; width: 30%; "  />

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 <div style="text-align:center"><span data-font="H2" style="font-family: Arial,Helvetica,sans-serif; font-size: 22px; line-height: 32px; color: #444444; font-weight: bold; font-style: normal; text-decoration: none;"><span style="font-size:13px"><span style="color:#dddddd">EPISODE 19 | 12 MIN | 31 August. 2022</span></span></span><br />
<span data-font="bodyFont" style="font-family: Arial,Helvetica,sans-serif; font-size: 14px; line-height: 16px; color: #000000; text-decoration: none; font-weight: normal; font-style: normal;"><span style="font-size:12px"><em><span style="font-size:13px"><span style="color:#dddddd">#Drug Review   #R&D   #Business   #Policy</span></span></em></span></span><br />
<span data-font="H3" style="font-family: Arial,Helvetica,sans-serif; font-size: 20px; line-height: 26px; color: #444444; font-weight: normal; font-style: normal; text-decoration: none;"><span style="font-size:18px"><strong><span style="color:#dddddd">EU issues GMP Annex 1 final revision for sterile drug products</span></strong></span></span><br />
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<span data-font="H4" style="font-family: Arial,Helvetica,sans-serif; font-size: 16px; line-height: 22px; color: #444444; font-weight: normal; font-style: normal; text-decoration: none;"><span style="color:#dddddd"><span style="font-size:13px">In the last week's Chinese pharma market, the 11th indication of BeiGene’s PD-1 Tislelizumab was declared for marketing for the treatment of esophageal squamous cell carcinoma.<br />
<br />
While in the global pharma market, Johnson & Johnson’s Teclistamab was approved by the EC, making it the first BCMA/CD3 bispecific antibody approved for marketing worldwide. In addition, the EU officially released the eagerly anticipated final revision of its GMP Annex 1 for sterile drug products. </span></span></span></div>

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<span style="font-size:28px"><strong><span style="color:#004040">22</span></strong></span><br />
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<span style="font-size:13px"><span style="color:#004040"><strong>4:00 pm CET | </strong></span></span><span style="font-size:13px"><span style="color:#004040"><strong>10:00 am EST</strong></span></span></div>

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<strong><span style="font-size:16px"><span style="color:#004040">China’s Quality and Therapeutic Equivalence Evaluation of Generic Drugs</span></span></strong></span><br />
 
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        <li><span data-font="bodyFont" style="font-family: Arial,Helvetica,sans-serif; font-size: 14px; line-height: 16px; color: #000000; text-decoration: none; font-weight: normal; font-style: normal;"><span style="color:#004040"><span style="font-size:13px">Regulatory Requirements of Quality and Therapeutic Equivalence Evaluations of Generic Drugs</span></span></span></li>
        <li><span data-font="bodyFont" style="font-family: Arial,Helvetica,sans-serif; font-size: 14px; line-height: 16px; color: #000000; text-decoration: none; font-weight: normal; font-style: normal;"><span style="color:#004040"><span style="font-size:13px">How Equivalence Evaluation Impacts Pharma Market</span></span></span></li>
        <li><span data-font="bodyFont" style="font-family: Arial,Helvetica,sans-serif; font-size: 14px; line-height: 16px; color: #000000; text-decoration: none; font-weight: normal; font-style: normal;"><span style="color:#004040"><span style="font-size:13px">Applications for Equivalence Evaluation</span></span></span></li>
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