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 原料藥發展委員會98年度第2次工作會議
日期：98.4.10
時間：15:30-17:30
會議主席：蘇張和惠主委、楊國彥主委
參加人員：
陳煙平（恆亞）、林明楷（正豐）、楊博惠（弘亞）、張明權（勝達）、
滕光政（川聖）、王逸慶（鴻汶）、陳青蓉（百歐敏）、葉陽河（東信）、
張靜芬（漢旭）、趙博瑞（瑞升）
討論議題：
壹、「提昇原料藥品質—自用原料之管理」因應對策。
說明：根據衛生署於4月6日召開「提昇原料藥品質—自用原料之管理」之說明會，衛生署要求公協會於10天內針對”自用原料之管理”提出相關建議案，為此次召開會議之目的。
一、 本委員會需於10天內針對”自用原料之管理”提出相關建議案。
二、 鼓勵部份：
若原枓藥來源有GMP證明，只需在第一次進口前，申請自用原料藥時，檢附所欲進口批號之原廠成績書(COA)，並於三個月內，後補檢附藥廠化驗的成績書(COA)，之後第二次起如為相同之來源者，得免逐批檢送成績書(COA) 。
三、 提升品質部份：
1. 成績書 (COA)內容是否應包含殘餘溶劑。
2. 成績書 (COA)是否包含不純物(Impurity profile)。
結 論：
本公會研擬之建議如下：
(一)原料藥有GMP證書者：
1. 提出GMP證書之Copy版或pdf檔即可，不需簽證。（因國外簽證需時三個月以上，而且國外原料藥供應商增加處理時間及成本，恐會延長進口所需時間。）
2. 提出PMF No.可代替GMP證書。
3. 可用電子檔代替書面文件送件，藥政處應於一星期內審核完竣並以電子檔回覆。
4. 有GMP證書，不收1,500元自用原料申請規費。
5. 可上網查詢申請審查進度。
(二)原料藥無GMP證書者：
藥政處審查期限可延長至二星期，其他應與有GMP證書者相同。
(三)自用原料來源變動頻繁（不同來源）者：
因為原料藥進口商無法掌握藥廠委託誰進口，故其審核期限應無不同。
貳、 臨時動議
案由：
業者對於藥政管理有疑義而函詢，目前藥政處每件收費1,500元，極不合理，應予廢除，或降低收費。
說明：
雖然依行政程序法第52條，行政機關可對當事人或利害關係人因行政程序所發生之費用要求由其負擔。但本營業團體所有會員均已依法納稅，對於藥政管理有疑義而函詢時，主管單位應依主管責任回覆，而不宜另行收取高額費用，以減低函詢意願。故懇請衛生署體恤民情予以廢除或降低收費。
決議：
建議廢除函詢收費1,500元，或降低收費。
參、 檢附U.S.FDA有關Baxter recall Heparin之公告（如下）供參考。
U.S. Food and Drug Administration
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products
Contact:
Erin Gardiner, (847) 948-4210
Deborah Spak, (847) 948-2349
FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., February 28, 2008 – Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.
The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.
Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.
Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.
This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.
"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."
Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.
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