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mvgchakravarthi ☆ India, 2010-09-07 20:11 (5775 d 03:51 ago) Posting: # 5890 Views: 4,291 |
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Could anybody suggest the regulatory requirement of Pharmaceutical alternatives for US/EU markets. Thanks inadvance Regards M.V.G.chakravarthi |
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Helmut ★★★   Vienna, Austria, 2010-09-08 18:54 (5774 d 05:08 ago) @ mvgchakravarthi Posting: # 5895 Views: 3,542 |
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Dear M.V.G. Chakravarthi! ❝ Could anybody suggest the regulatory requirement of Pharmaceutical ❝ alternatives for US/EU markets. The main difference between US and EU is that in the US only pharmaceutical equivalents (e.g., generic tablet vs. RLD tablet) qualify for an ANDA, whereas in the EU one may get also regulatory approval for pharmaceutical alternatives (e.g., IR capsule vs. reference IR tablet). For details have a look at the Guideline-Collection: US-FDA, EU-EMA. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Noha Abdeljawad ☆ Cairo, Egypt, 2014-08-25 15:06 (4327 d 08:57 ago) @ Helmut Posting: # 13428 Views: 2,675 |
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Dear Helmut, ❝ whereas in the EU one may get also regulatory approval for pharmaceutical alternatives (e.g., IR capsule vs. reference IR tablet). ❝ For details have a look at the Guideline-Collection: US-FDA, EU-EMA. Could you please refer me to the part of the guidelines that says that you can use a pharmaceutical alternative reference (if the pharmaceutical equivalent is unavailable). The only lines I could find were on page 7/27, "In an application for extension of a medicinal product which has been initially approved under Art.8(3) of Directive 2001/83/EC and when there are several dosage forms of this medicinal product on the market, it is recommended that the dosage form used for the initial approval of the concerned medicinal product (and which was used in clinical efficacy and safety studies) is used as reference product, if available on the market." Thanks — Best Regards Noha Abdeljawad |
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Naveen Kumar ☆ India, 2014-08-26 09:43 (4326 d 14:20 ago) @ Noha Abdeljawad Posting: # 13432 Views: 2,639 |
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Dear Noha, GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE, London, 20 January 2010, From page 4 of 27, Section 1.1 Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent)after administration in the same molar dose lie within acceptable predefined limits. Thanks, Naveen Kumar.SR |
Ing. Helmut Schütz